1
|
Wang T, Villanueva DJ, Banerjee A, Gifkins D. Reporting and representation of participant race and ethnicity in phase III clinical trials for solid tumors. Future Sci OA 2025; 11:2458415. [PMID: 39885684 PMCID: PMC11792851 DOI: 10.1080/20565623.2025.2458415] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2024] [Accepted: 12/24/2024] [Indexed: 02/01/2025] Open
Abstract
BACKGROUND Including racial and ethnic minorities in clinical trials is essential for advancing health equity. Despite progress, trials often do not mirror patient population demographics. METHODS The National Library of Medicine's Clinical Trials database was queried for phase III trials of lung, colorectal, breast, and prostate cancers. A reference population was identified from the Surveillance, Epidemiology, and End Result (SEER) database, covering 48% of the US population. RESULTS Among 181 trials, race and ethnicity data were included in 86.7% and 60.2% of trials, respectively, with improving reporting over time. Participants were predominantly White (76.3%), followed by Asian/Pacific Islander (14.1%), Black/African American (4.5%), and American Indian/Alaska Native (0.6%). Hispanic/Latino constituted 6.4% of participants. The proportion of non-White groups increased from 19.4% in trials started before 2011 to 26.2% after 2015. Compared with SEER data, the percentages were lower for Asian/Pacific Islander across all cancers, Black/African American in breast and prostate cancers, American Indian or Alaska Native in colorectal, breast, and prostate cancers in US solely trials. CONCLUSIONS Reporting and enrollment of racial and ethnic minorities in trials remain inadequate but improving. To enhance diversity, real-world data are warranted to identify recruitment goals by better assessing the geographic distribution within the patient population.
Collapse
Affiliation(s)
- Tianyi Wang
- Janssen Research & Development LLC, Raritan, NJ, USA
| | | | | | - Dina Gifkins
- Janssen Research & Development LLC, Raritan, NJ, USA
| |
Collapse
|
2
|
Witt M, Shaffer M, Torres A, Santoro SL. Research Letter: Recruiting a Diverse Cohort in Genetics Research-Reflecting on Demographic Representation in a Down Syndrome Survey. Am J Med Genet A 2025:e64111. [PMID: 40391503 DOI: 10.1002/ajmg.a.64111] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/09/2024] [Revised: 04/07/2025] [Accepted: 04/28/2025] [Indexed: 05/21/2025]
Affiliation(s)
- Mary Witt
- Down Syndrome Program, Division of Medical Genetics and Metabolism, Department of Pediatrics, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Mikayla Shaffer
- Down Syndrome Program, Division of Medical Genetics and Metabolism, Department of Pediatrics, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Amy Torres
- Down Syndrome Program, Division of Medical Genetics and Metabolism, Department of Pediatrics, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Stephanie L Santoro
- Down Syndrome Program, Division of Medical Genetics and Metabolism, Department of Pediatrics, Massachusetts General Hospital, Boston, Massachusetts, USA
- Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA
| |
Collapse
|
3
|
Li M, He J, Vanderbeek BL, Ying GS. Racial and Ethnic Disparities at Enrollment in DRCRnet Clinical Trials for Diabetic Macular Edema. Am J Ophthalmol 2025; 273:231-239. [PMID: 40020979 DOI: 10.1016/j.ajo.2025.02.029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/20/2024] [Revised: 02/18/2025] [Accepted: 02/20/2025] [Indexed: 03/03/2025]
Abstract
PURPOSE To assess racial/ethnic disparities and association with diabetic macular edema (DME) characteristics at enrollment in DRCR Retina Network (DRCRnet) DME clinical trials. DESIGN Retrospective, cross-sectional analysis of data from DRCRnet clinical trials. SUBJECTS 5468 participants in 17 DRCRnet DME trials (2003-2020). METHODS The racial and ethnic distribution of DRCRnet DME trial participants was compared to United States census data and DME prevalence data in the CDC's Vision and Eye Health Surveillance System (VEHSS). Generalized linear models were used for comparing demographics, HgbA1c, diabetic retinopathy (DR) severity, and visual acuity (VA) among racial/ethnic groups, and for determining factors associated with VA. MAIN OUTCOME MEASURES Racial and ethnic distribution of DME trial participants; patient and ocular characteristics at enrollment. RESULTS Compared to VEHSS (64% White, 16% Black, 4% Asian, 14% Hispanic) and the 2020 U.S. census (62% White, 12% Black, 6% Asian, 19% Hispanic), White (76%) participants were over-represented, and Asians (2%) and Hispanics (12%) were under-represented (P < .001) in DME trials. HgbA1c was higher in Black and Hispanic (8.3) than in White (7.7) and Asian (7.6) participants (P < .001). More Asian (20%) and Hispanic (23%) participants had proliferative DR than White (19%) and Black (15%) participants (P < .001). Hispanic ethnicity, female gender, older age at diabetes diagnosis, and severe DR were independently associated with worse VA (all P < .05). CONCLUSIONS Hispanic participants, while under-represented, had higher HgbA1c, more severe DR, and worse VA than other groups, emphasizing the need for diverse recruitment in DME trials.
Collapse
Affiliation(s)
- Melissa Li
- From the Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Jocelyn He
- From the Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Brian L Vanderbeek
- From the Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Gui-Shuang Ying
- From the Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA..
| |
Collapse
|
4
|
Wood E, Sherry R, Jones G, Babek JT, Howard H, Hemmerich C, Koontz A, Langley JM, Ford AI, Vassar M. Evaluating Diversity in Thyroid Cancer Clinical Trials: Application of the Clinical Diversity Rating Framework. Head Neck 2025. [PMID: 40264283 DOI: 10.1002/hed.28173] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2024] [Revised: 01/28/2025] [Accepted: 04/15/2025] [Indexed: 04/24/2025] Open
Abstract
BACKGROUND Despite progress in recruiting representative patient samples for clinical trials, disparities persist. This study quantifies the representation of historically marginalized groups-female patients, members of racial/ethnic minority groups, and older patients-in thyroid cancer clinical trials and proposes strategies for improving their participation. METHODS We performed a systematic review and meta-analysis of thyroid cancer treatment studies conducted in the United States and published between January 2018 and December 2023, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes (PRISMA) guidelines. Studies were sourced from EMBASE and PubMed. Independent and duplicate screening and data extraction were conducted to ensure accuracy. Extracted data included trial interventions, clinical phases, sample sizes, demographic characteristics of participants, and funding sources. Studies were evaluated using the Clinical Trial Diversity Rating framework to assess the inclusion rates of diverse participant groups compared to their prevalence rates for thyroid cancer. RESULTS We found that US-based clinical trials for thyroid cancer frequently underrepresented female and non-white individuals. In over half of studies, male participants outnumbered female participants. Reporting of race and ethnicity information was inadequate, with 9/13 studies failing to provide any demographic breakdown. Among the four studies that did report race and ethnicity data, none achieved adequate representation of minority patients. Additionally, there was a notable lack of reporting on participant age bands, despite the relatively high incidence of thyroid cancer in adults aged 60 and above. CONCLUSIONS Our findings highlight the persistent underrepresentation of women, non-white racial/ethnic groups, and older adults in thyroid cancer trials. Urgent efforts are needed to address these disparities, particularly given the increasing rates of thyroid cancer among women and the healthcare access disparities in marginalized communities.
Collapse
Affiliation(s)
- Ethan Wood
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
| | - Ryan Sherry
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
| | - Garrett Jones
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
| | - J Tyler Babek
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
| | - Haley Howard
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
| | - Christian Hemmerich
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
| | - Alexandra Koontz
- Department of Otolaryngology-Head and Neck Surgery, Oklahoma State University Medical Center, Tulsa, Oklahoma, USA
| | - Jean-Maria Langley
- Department of Otolaryngology-Head and Neck Surgery, Oklahoma State University Medical Center, Tulsa, Oklahoma, USA
| | - Alicia Ito Ford
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
- Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
| | - Matt Vassar
- Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
- Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
| |
Collapse
|
5
|
Byiringiro S, Garcia JK, Farrell N, Ogungbe B, Barsha RAA, Miller HN, Whitaker E, Wang P, Rosa WE, Bierer BE, Himmelfarb CR, Michos ED, De Lombaert K, Berdichesky M, Busque S, Palaniappan L, Lewis E, Rodriguez F, Valantine H. Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America. Trials 2025; 26:117. [PMID: 40176184 PMCID: PMC11963400 DOI: 10.1186/s13063-025-08820-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2025] [Accepted: 03/19/2025] [Indexed: 04/04/2025] Open
Abstract
The lack of diversity in clinical studies has significant ethical and health consequences, limiting the development of effective treatments for diverse populations. Homogeneous participation in clinical studies contributes to health disparities, particularly among historically underrepresented groups in the United States (US). Racial, ethnic, and other minoritized populations have long been excluded from clinical research. In response, the US Congress mandated the National Institutes of Health to assess the impacts of insufficient diversity in clinical studies. Despite efforts by the government, non-profit organizations, and industry players to improve diversity in clinical studies, progress has been slow due to fragmented approaches. For instance, the new US administration (2025) has recently released executive orders which threaten to reverse the progress made in inclusive clinical research. The Stanford Think Tank on Diversity and Equity in Clinical Trials, held in September 2023, brought together key partners across multiple sectors and professions to discuss barriers and explore potential solutions to participation in clinical studies. In this commentary, we discuss the importance of collaborative, inclusive strategies in clinical study design to advance equitable health outcomes for all. Further, we discuss potential implications of the government's dismissal of diversity, equity, and inclusion initiatives on diverse research participation.
Collapse
Affiliation(s)
- Samuel Byiringiro
- School of Nursing, Johns Hopkins University, 525 N Wolfe St, Baltimore, MD, 21205, USA.
| | - Juliana K Garcia
- Elson S Floyd College of Medicine, Washington State University, Spokane, USA
| | | | - Bunmi Ogungbe
- School of Nursing, Johns Hopkins University, 525 N Wolfe St, Baltimore, MD, 21205, USA
| | | | - Hailey N Miller
- School of Nursing, Johns Hopkins University, 525 N Wolfe St, Baltimore, MD, 21205, USA
| | - Evans Whitaker
- Lane Medical Library, Stanford University, Palo Alto, USA
| | - Paul Wang
- School of Medicine, Stanford University, Stanford, USA
| | - William E Rosa
- Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, USA
| | - Barbara E Bierer
- Multi-Regional Clinical Trials Center of Brigham and Women'S Hospital and Harvard, Boston, MA, USA
- Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
| | - Cheryl R Himmelfarb
- School of Nursing, Johns Hopkins University, 525 N Wolfe St, Baltimore, MD, 21205, USA
| | - Erin D Michos
- School of Medicine, Johns Hopkins University, Baltimore, USA
| | | | | | | | | | - Eldrin Lewis
- School of Medicine, Stanford University, Stanford, USA
| | | | | |
Collapse
|
6
|
Smith AJB, Spataro S, Heintz J, Simpkins F, Ko EM. Disparities in clinical drug trial participation in endometrial cancer: a real-world analysis. Am J Obstet Gynecol 2025; 232:379.e1-379.e12. [PMID: 39349272 DOI: 10.1016/j.ajog.2024.09.103] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2024] [Revised: 09/18/2024] [Accepted: 09/24/2024] [Indexed: 10/02/2024]
Abstract
BACKGROUND Racial disparities in clinical trial participation for uterine cancer have been reported. OBJECTIVE We sought to examine disparities of endometrial cancer patient participation in clinical drug trials in a contemporary, real-world population in the United States. STUDY DESIGN We conducted a retrospective cohort study of patients with advanced or recurrent patients with endometrial cancer diagnosed from 2013 to 2021 using a real-world electronic health record-derived database representing approximately 800 academic and community practice sites across the United States. We used multilevel Poisson regression modeling to analyze the association of clinical drug trial participation with patient, sociodemographic, health system, and cancer factors. RESULTS Of 4423 patients with endometrial cancer, 2807 (63.5%) identified as white, 649 (14.7%) Black, 78 (1.8%) Asian, and 964 (21.8%) some other race. Overall, 3.8% of patients with endometrial cancer ever participated in a clinical drug trial. High-risk histology and residence in the Southeast were associated with increased clinical trial participation (risk ratio (RR) 2.28, 95% confidence interval (CI) 1.12-4.62 and RR 2.59, 95% CI 1.26-5.3 respectively). By race, trial participants included 123 (72.4%) White, 18 (10.6%) Black, 1 (0.59%) Asian, and 28 (16.4%) some other race. While Black patients had the greatest proportion of high-risk histology, they were 50.0% less likely than white patients to participate in a clinical trial (RR 0.50, 95% CI 0.30-0.83). CONCLUSION Black patients with endometrial cancer were disproportionately underrepresented in clinical drug trials, despite having higher rates of aggressive cancer histologies. Efforts to increase diversity in endometrial cancer clinical trial participants are needed.
Collapse
Affiliation(s)
- Anna Jo Bodurtha Smith
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania Health Systems, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania Health Systems, Philadelphia, PA; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania Health Systems, Philadelphia, PA.
| | - Sebastian Spataro
- Leonard Davis Institute of Health Economics, University of Pennsylvania Health Systems, Philadelphia, PA; Rice University, Houston, TX; Population Aging Research Center, Penn Arts and Sciences Populations Studies Center, University of Pennsylvania, Philadelphia, PA
| | - Jonathan Heintz
- Biostatistics Analysis Center, Perelman School of Medicine, University of Pennsylvania Health Systems, Philadelphia, PA
| | - Fiona Simpkins
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania Health Systems, Philadelphia, PA
| | - Emily M Ko
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania Health Systems, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania Health Systems, Philadelphia, PA; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania Health Systems, Philadelphia, PA
| |
Collapse
|
7
|
Faisal S, Birchley G, Wade J, Lane A, Malik F, Yardley T, Dawson S. Understanding Barriers and Facilitators for Ethnic Minority Groups to Audio Recording Recruitment Discussions in Clinical Trials: A Participatory Approach to Improving Informed Consent and Participation. Health Expect 2025; 28:e70210. [PMID: 40098296 PMCID: PMC11913728 DOI: 10.1111/hex.70210] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2024] [Revised: 02/08/2025] [Accepted: 02/21/2025] [Indexed: 03/19/2025] Open
Abstract
INTRODUCTION Fully informed consent is essential for ethical trial conduct, yet gaps in participant comprehension and recall can occur, particularly among underserved groups, for example, ethnic minorities. This Patient and Public Involvement and Engagement (PPIE) project explored the engagement of ethnic minority communities in trial recruitment discussions, particularly their views about audio recording discussions with healthcare professionals. METHODS This PPIE project engaged ethnic minority communities in Bristol, collaborating with community partners to facilitate access to then foster dialogue among Somali, South Asian and Chinese groups. Separate workshops for men and women from these ethnic groups were held to introduce community members to clinical trial processes. Discussions, both audio recorded and not, simulated real recruitment scenarios. To ensure cultural relevance and accessibility, discussions were partly facilitated by our PPIE community partners in native languages. RESULTS The insights gained during workshops were organised into key themes. Gaps in understanding regarding clinical trial participation were highlighted. A key finding was that trust played an important role and was facilitated by engaging community leaders and ensuring cultural and linguistic sensitivity during discussions. To address gaps in knowledge about trials and streamline the educational process, we developed storyboards and multilingual video resources. These explained the importance of clinical trials generally and the importance of recruiting diverse patient populations in particular. The materials were co-created with community partners and refined through iterative feedback to ensure accuracy and cultural appropriateness. The challenge of language barriers necessitated skilled interpreters, especially when discussions were audio recorded, to optimise understanding among people from diverse ethnic backgrounds. The video, available in English, Urdu, Mandarin, Cantonese and Bangla, facilitates understanding of trial purposes and processes, with the aim of widening trial participation in these groups. CONCLUSION Our PPIE activities highlighted gaps in understanding, the critical role of trust and the challenge of language barriers. The co-created resources have been made available for those wanting to address and overcome some of these issues. The initial feedback from the clinical trials community on the video resources has been promising, underscoring their potential to impact future recruitment efforts and PPIE activities. PATIENT OR PUBLIC CONTRIBUTION To foster a co-creation process, this project included the active involvement of our PPIE collaborators and co-applicants 'Khaas' for funding. They also helped us reach contributors from the South Asian community (mainly of Pakistani and Bangladeshi origin) and arrange workshops. Our two PPIE contributors from Somali Resource Centre and Barton Hill Activity Club helped us reach the Somali community at the Wellspring Settlement. Similarly, the Chinese Community Wellbeing Society helped us reach people from the Chinese community. These PPIE partners also helped us run the workshop by providing live translation of discussion. They also helped translate video scripts and do voiceovers in videos. Also, PPIE contributors Tom Yardley and Amanda Roberts helped with the script development.
Collapse
|
8
|
Mills K, Figueroa F, Knight R, Ekpo E, Lee LC, Baldo L, Xu C, Wang S, Adelman RM, Pemu P, Levin T, Shaukat A, Liu JJ. Fact or Myth? Black Patients Do Not Want to Participate in Clinical Trials. Clin Transl Gastroenterol 2025; 16:e00826. [PMID: 39878425 PMCID: PMC12020698 DOI: 10.14309/ctg.0000000000000826] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/03/2025] [Accepted: 01/21/2025] [Indexed: 01/31/2025] Open
Abstract
INTRODUCTION To assess strategies for optimizing participation of underserved minorities in a blood-based early colorectal cancer detection test study (PREEMPT CRC; NCT04369053) at a hospital serving primarily Black individuals. METHODS Culturally sensitive, racially congruent research staff approached individuals undergoing average-risk screening colonoscopy. Consent/study procedures were synchronized with clinical appointments. Enrolled and not-enrolled patient characteristics were compared. Recruitment was compared with other study sites. RESULTS In total, 247 of 509 eligible individuals were enrolled; most were identified as Black (88.7%). No baseline characteristics were associated with participation. Recruitment was high compared with other sites (11th centile). DISCUSSION Recruitment barriers for Black individuals can be overcome when easy, culturally sensitive access is facilitated.
Collapse
Affiliation(s)
- Krystal Mills
- Department of Medicine, Division of Gastroenterology, Morehouse School of Medicine, Atlanta, Georgia, USA
- Department of Gastroenterology and Hepatology, Mayo Clinic Rochester, Rochester, Minnesota, USA
| | | | - RaKetra Knight
- Department of Medicine, Division of Gastroenterology, Morehouse School of Medicine, Atlanta, Georgia, USA
| | - Emem Ekpo
- Department of Medicine, Division of Gastroenterology, Morehouse School of Medicine, Atlanta, Georgia, USA
| | | | - Lance Baldo
- Freenome Inc, South San Francisco, California, USA
| | - Chuanbo Xu
- Freenome Inc, South San Francisco, California, USA
| | - Siqi Wang
- Department of Sociology, University at Buffalo, Buffalo, New York, USA
| | - Robert M. Adelman
- Department of Sociology, University at Buffalo, Buffalo, New York, USA
| | - Priscilla Pemu
- Department of Medicine, Morehouse School of Medicine, Atlanta, Georgia, USA
| | - Theodore Levin
- Kaiser Permanente Division of Research, Pleasanton, California, USA
| | - Aasma Shaukat
- Department of Medicine, Division of Gastroenterology, NYU Grossman School of Medicine, New York, New York, USA
| | - Julia J. Liu
- Department of Medicine, Division of Gastroenterology, Morehouse School of Medicine, Atlanta, Georgia, USA
| |
Collapse
|
9
|
Hadeed M, Badger TA, Segrin C, Robles-Morales R, Werts-Pelter SJ. Strategies for recruitment and retention of diverse and underserved cancer survivor and caregiver dyads in clinical trials. Contemp Clin Trials Commun 2025; 44:101425. [PMID: 39881887 PMCID: PMC11773091 DOI: 10.1016/j.conctc.2024.101425] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2024] [Revised: 12/13/2024] [Accepted: 12/31/2024] [Indexed: 01/31/2025] Open
Abstract
Background Cancer survivor-caregiver dyads from underrepresented racial and ethnic groups and those with lower socioeconomic status are less likely to participate in clinical research. Sociocultural and socioeconomic barriers perpetuate health inequity and increase disparities in cancer care. Purpose We describe our systematic approach to recruiting and retaining diverse survivor-caregiver dyads in supportive cancer care studies. Methods Matsuda's research recruitment guidelines of evaluate, engage, reflect, and carefully match ("EERC") were adapted and applied through a framework of six guiding principles. Results A systematic approach to recruitment of underrepresented dyads in cancer support research includes 1) Developing a bilingual, bicultural study team with shared language and culture of the study population, 2) Ensuring team members share a passion for cancer health equity and are trained with a community-centric approach, 3) Designing accessible interventions, study materials, and shared data collection tools across similar studies with community and stakeholder input, 4) Engaging local and regional stakeholders with expertise of health disparities among the catchment area, 5) Partnering with Community Health Workers (CHWs) and gatekeepers to enhance community presence, and 6) Ensuring careful application of matching study team members and participants beyond race and ethnicity to prioritize the cultural values and social factors that impact cancer survivors and caregivers. Conclusion Applying a systematic approach to recruiting and retaining underrepresented dyads in cancer research can potentially reduce sociocultural and socioeconomic barriers to cancer health equity.
Collapse
Affiliation(s)
- Mary Hadeed
- Nursing and Health Science Division, University of Arizona College of Nursing, Tucson, AZ, USA
- University of Arizona Mel and Enid Zuckerman College of Public Health, Tucson, AZ, USA
| | - Terry A. Badger
- Nursing and Health Science Division, University of Arizona College of Nursing, Tucson, AZ, USA
- University of Arizona Mel and Enid Zuckerman College of Public Health, Tucson, AZ, USA
- Department of Clinical Translational Sciences, University of Arizona College of Health Sciences, Tucson, AZ, USA
- University of Arizona Cancer Center, Tucson, AZ, USA
| | - Chris Segrin
- Department of Communications, University of Arizona, Tucson, AZ, USA
| | - Rogelio Robles-Morales
- Department of Clinical Translational Sciences, University of Arizona College of Health Sciences, Tucson, AZ, USA
| | | |
Collapse
|
10
|
Solomon E, Gupta M, Su R, Reinhart N, Battistoni V, Mittal A, Bronheim RS, Silva-Aponte J, Cartagena Reyes M, Hawkins D, Joshi A, Kebaish KM, Hassanzadeh H. Trends and Rates of Reporting of Race, Ethnicity, and Social Determinants of Health in Spine Surgery Randomized Clinical Trials: A Systematic Review. Clin Spine Surg 2025; 38:123-131. [PMID: 39226156 DOI: 10.1097/bsd.0000000000001675] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/11/2023] [Accepted: 06/28/2024] [Indexed: 09/05/2024]
Abstract
STUDY DESIGN A systematic review. OBJECTIVE We characterized the rates of sociodemographic data and social determinants of health (SDOH) reported in spinal surgery randomized control trials (RCTs) and the association between these RCTs' characteristics and their rates of reporting on race, ethnicity, and SDOH variables. SUMMARY OF BACKGROUND DATA Although numerous institutions maintain guidelines and recommendations regarding the inclusion and reporting of sociodemographic and SDOH variables in RCTs, the proportion of studies that ultimately report such information is unclear, particularly in spine surgery. MATERIALS AND METHODS We searched the MEDLINE, PubMed, and Embase databases for published results from spinal surgery RCTs from January 2002 through December 2022, and screened studies according to prespecified inclusion criteria regarding analysis and reporting of sociodemographic and SDOH variables. RESULTS We analyzed 421 studies. Ninety-six studies (22.8%) reported race, ethnicity, or SDOH covariates. On multivariate analysis, study size [rate ratio (RR)=1.18; 95% CI, 1.06-1.32], public/institutional funding (RR=2.28; 95% CI, 1.29-4.04), and private funding (RR=3.27; 95% CI, 1.87-5.74) were significantly associated with reporting race, ethnicity, or SDOH variables. Study size (RR=1.26; 95% CI, 1.07-1.48) and North American region (RR=21.84; CI, 5.04-94.64) were associated with a higher probability of reporting race and/or ethnicity. Finally, study size (RR=1.27; 95% CI, 1.10-1.46), public/institutional funding (RR=2.68; 95% CI, 1.33-5.39), focus on rehabilitation/therapy intervention (RR=2.70; 95% CI, 1.40-5.21), and nonblinded study groups (RR=2.70; 95% CI, 1.40-5.21) were associated with significantly higher probability of reporting employment status. CONCLUSION Rates of reporting race, ethnicity, and SDOH variables were lower in the spinal surgery RCTs in our study than in RCTs in other medical disciplines. These reporting rates did not increase over a 20-year period. Trial characteristics significantly associated with higher rates of reporting were larger study size, North American region, private or public funding, and a focus on behavioral/rehabilitation interventions. LEVEL OF EVIDENCE Level III.
Collapse
Affiliation(s)
- Eric Solomon
- Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, MD
| | - Mihir Gupta
- Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, MD
| | - Rachel Su
- University of South Florida Morsani College of Medicine, Tampa, FL
| | - Nolan Reinhart
- University of South Florida Morsani College of Medicine, Tampa, FL
| | | | - Aditya Mittal
- University of Pittsburgh School of Medicine, Pittsburgh, PA
| | - Rachel S Bronheim
- Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, MD
| | - Juan Silva-Aponte
- Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, MD
| | | | - Devan Hawkins
- Public Health Program, School of Arts and Sciences, Massachusetts College of Pharmacy and Health Sciences, Boston, MA
| | - Aditya Joshi
- Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, MD
| | - Khaled M Kebaish
- Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, MD
| | - Hamid Hassanzadeh
- Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, MD
| |
Collapse
|
11
|
Williford DN, Burstein E, Modi AC, Crosby LE, Stark LJ, Rybak TM. Harnessing Mother's Strengths to THRIVE in Obesity Prevention Efforts: A Qualitative Study. CLINICAL PRACTICE IN PEDIATRIC PSYCHOLOGY 2025; 13:26-36. [PMID: 40365449 PMCID: PMC12068807 DOI: 10.1037/cpp0000515] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/15/2025]
Abstract
Objectives Infancy is a critical period for preventing obesity and health disparities. This study reports on the acceptability of a responsive parenting obesity prevention intervention (THRIVE) delivered via integrated behavioral health in a pediatric primary care setting. Intervention participants were invited to participate in a focus group on the acceptability of THRIVE and suggestions for refinement with particular attention to cultural responsiveness and diversity, equity, inclusion, and accessibility (DEIA). Methods Eleven of 32 (34.4%) mothers participated in a 45-60 minute focus group (three groups, 3-5 participants each). Sessions utilized a semi-structured interview guide, were transcribed verbatim, and analyzed according to a thematic analytic approach. Results Four themes emerged: (1) Lived Experience (e.g., lived experience as a mother, navigating systemic and healthcare-related barriers, and context that shaped personal experiences with THRIVE); (2) Therapeutic Processes and Cultural Responsiveness (e.g., an appreciation of families' strengths and values by the THRIVE interventionist that facilitated engagement with THRIVE); (3) Tailored Strategy Implementation (e.g., implementation of THRIVE skills and strategies by families and how strategies were adapted or tailored to meet families' needs); (4) Future Improvements to THRIVE (e.g., proposed strategies for increased attention to DEIA and reducing participant burden). Conclusions Conducting qualitative research prior to Phase 2-3 trials is vital to ensuring the interventions developed, implemented, and tested are not only empirically-based, but also culturally-responsive, attentive to DEIA, acceptable and relevant. Mothers provided valuable insights surrounding participation in THRIVE, highlighting important DEIA elements of THRIVE and suggested ways to decrease burden and increase access.
Collapse
Affiliation(s)
| | | | - Avani C. Modi
- Cincinnati Children’s Hospital Medical Center
- University of Cincinnati College of Medicine
| | - Lori E. Crosby
- Cincinnati Children’s Hospital Medical Center
- University of Cincinnati College of Medicine
| | - Lori J. Stark
- Cincinnati Children’s Hospital Medical Center
- University of Cincinnati College of Medicine
| | - Tiffany M. Rybak
- Cincinnati Children’s Hospital Medical Center
- University of Cincinnati College of Medicine
| |
Collapse
|
12
|
Podany EL, Foffano L, Gerratana L, Medford AJ, Clifton K, Tapiavala S, Velimirovic M, Lipsyc-Sharf M, Reduzzi C, Bubie A, Putur A, Ademuyiwa FO, Puglisi F, Gradishar WJ, Ma CX, Bardia A, Cristofanilli M, Davis AA. Racial Differences in ctDNA Profiles, Targeted Therapy Use, and Outcomes in Metastatic Breast Cancer. JAMA Netw Open 2025; 8:e2461899. [PMID: 40009379 PMCID: PMC11866032 DOI: 10.1001/jamanetworkopen.2024.61899] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/22/2024] [Accepted: 12/22/2024] [Indexed: 02/27/2025] Open
Abstract
Importance Black patients with metastatic breast cancer (mBC) have higher mortality rates than White patients despite advances in treatment. Objectives To examine whether Black patients with metastatic breast cancer have different genomic profiles compared with White patients and whether there are inequities in targeted treatment use between these groups. Design, Setting, and Participants This retrospective, population-based cohort study assessed adult patients with mBC who underwent genomic profiling at academic institutions in the US between January 1, 2015, and December 31, 2023. Data analysis was performed between July 2023 and July 2024. A validation cohort was also included. Exposures Targeted treatment use. Main Outcomes and Measures The main outcomes were differences in circulating tumor DNA profiles and use of phosphoinositide 3-kinase (PI3K), mammalian target of rapamycin (mTOR), and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors between Black and White patients with metastatic breast cancer. Results The study sample included 1327 women with mBC (mean [SD] age, 58.0 [12.8] years; 140 Black and 1057 White). Black patients had a significantly higher rate of GATA3 single-nucleotide variants (odds ratio, 2.31; 95% CI, 1.17-4.54; P = .02) and CCND2 copy number variants (odds ratio, 4.63; 95% CI, 1.79-11.97; P = .002) on multivariate analysis. These differences were validated in a population-based evidence cohort of 27 224 patients. Black patients with PIK3CA single-nucleotide variants were significantly less likely to receive PI3K inhibitors than White patients (1 of 17 [5.9%] vs 45 of 156 [28.8%]; P = .04), whereas there was no difference in use of CDK4/6 and mTOR inhibitors, which do not require a targetable alteration. Black patients had a shorter overall survival from the time of circulating tumor DNA testing compared with White patients. Conclusions and Relevance This cohort study of patients with mBC found somatic differences, shorter overall survival, and targeted treatment disparities in PI3K inhibitor use in Black compared with White patients despite equal incidence of PIK3CA alterations. Researchers should consider these differences when designing future research and interventions to address the striking and persistent outcomes gap between Black and White patients with mBC.
Collapse
Affiliation(s)
- Emily L. Podany
- Department of Medicine, Washington University in St Louis, St Louis, Missouri
| | - Lorenzo Foffano
- Department of Medicine, University of Udine, Udine, Italy
- Department of Medical Oncology, CRO Aviano, National Cancer Institute, IRCCS, Aviano, Italy
| | - Lorenzo Gerratana
- Department of Medicine, University of Udine, Udine, Italy
- Department of Medical Oncology, CRO Aviano, National Cancer Institute, IRCCS, Aviano, Italy
| | - Arielle J. Medford
- Department of Medicine, Massachusetts General Hospital Cancer Center, Boston
| | - Katherine Clifton
- Department of Medicine, Washington University in St Louis, St Louis, Missouri
| | - Shaili Tapiavala
- Department of Medicine, Washington University in St Louis, St Louis, Missouri
| | | | | | - Carolina Reduzzi
- Department of Medicine, Weill Cornell Medicine, New York, New York
| | | | - Annika Putur
- Department of Medicine, Massachusetts General Hospital Cancer Center, Boston
| | - Foluso O. Ademuyiwa
- Department of Medicine, Washington University in St Louis, St Louis, Missouri
| | - Fabio Puglisi
- Department of Medicine, University of Udine, Udine, Italy
- Department of Medical Oncology, CRO Aviano, National Cancer Institute, IRCCS, Aviano, Italy
| | | | - Cynthia X. Ma
- Department of Medicine, Washington University in St Louis, St Louis, Missouri
| | - Aditya Bardia
- Department of Medicine, UCLA Health, Los Angeles, California
| | | | - Andrew A. Davis
- Department of Medicine, Washington University in St Louis, St Louis, Missouri
| |
Collapse
|
13
|
Williams DM, Pflugeisen CM, Ameen K, Chen TK, Cooks S, Ray BC, Foster M, Phillips D, Sanchez L, Hardiman K, Smith C, Slim J. Promoting Racial Justice in Cancer Clinical Trials: Community Engaged Solutions for Bridging Gaps. Cancer Med 2025; 14:e70690. [PMID: 39969108 PMCID: PMC11837037 DOI: 10.1002/cam4.70690] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2024] [Revised: 01/17/2025] [Accepted: 02/05/2025] [Indexed: 02/20/2025] Open
Abstract
INTRODUCTION Racially and ethnically diverse populations are disproportionately burdened with and more likely to die from cancer than White populations but remain persistently underrepresented in cancer clinical trials. Thus, the safety and efficacy assessments of novel therapies may not apply to all populations, and guidelines are developed using trials that inadequately reflect our population. This study aims to explore healthcare experiences, cancer clinical trial perceptions, and solutions for bridging gaps in cancer clinical trials among communities of color. METHODS We held a series of five focus groups with 23 survivors and caregivers of color. These sessions explored perspectives around cancer care and research, clinical trials recruitment and messaging, and priorities around addressing the current insufficiency in representation in cancer research. RESULTS Our focus group data was analyzed using an inductive thematic approach. Four themes were present including (1) high motivation to participate in cancer trials and desire for better outreach and education within communities of color; (2) examples of just care as a model for improving access to clinical trials; (3) manifestations of power and inequity in healthcare inhibiting opportunities for clinical trial participation; and (4) the need for trust-building at the healthcare, community, and interpersonal levels. CONCLUSION Our findings demonstrate that people of color strongly desire clinical trial options and discussions during cancer care, and trust-building is foundational to opening pathways to research participation. We offer concrete steps for increasing racial justice in cancer clinical trials that serve as a point of reflection and guidance for healthcare professionals, researchers, and clinical trials teams.
Collapse
Affiliation(s)
- Deana M. Williams
- MultiCare Health System Institute for Research & InnovationPuyallupWashingtonUSA
| | - Chaya M. Pflugeisen
- MultiCare Health System Institute for Research & InnovationPuyallupWashingtonUSA
| | | | - Toby K. Chen
- Clinical Trials Advisory GroupPuyallupWashingtonUSA
| | - Sheree Cooks
- Clinical Trials Advisory GroupPuyallupWashingtonUSA
| | | | | | - De Phillips
- Clinical Trials Advisory GroupPuyallupWashingtonUSA
| | | | | | - Cynthia Smith
- MultiCare Health System Institute for Research & InnovationPuyallupWashingtonUSA
| | | |
Collapse
|
14
|
Zuckerman MC, Edwards HA. Diversity in U.S. Clinical Trials for Head and Neck Cancer: Are We Improving? Head Neck 2025; 47:679-686. [PMID: 39400951 DOI: 10.1002/hed.27943] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/09/2023] [Revised: 07/29/2024] [Accepted: 09/16/2024] [Indexed: 10/15/2024] Open
Abstract
BACKGROUND This study assesses whether national initiatives undertaken to improve diversity in clinical trial enrollment have been successful within head and neck cancer (HNC) trials. METHODS A retrospective analysis was conducted of HNC trials published on clinicaltrials.gov with start dates between 2000 and 2023. Demographic data for 8998 HNC trial enrollees was abstracted and analyzed to investigate potential demographic shifts. RESULTS In the past 20 years, the percentage of White patients increased 6.1%, Asian patient population decreased 3.1%, and Black patient population increased 0.8%. Compared with previously published SEER data, HNC trials have significantly more White patients, fewer Black patients, and fewer Asian/Native-Hawaiian patients than HNC patients at large. CONCLUSIONS Despite efforts to increase diversity in HNC clinical trials in the United States, diversity has significantly decreased in the past 10 years. As current approaches are failing to show improvement, novel approaches to improving representation in clinical trials are necessitated.
Collapse
Affiliation(s)
| | - Heather Ann Edwards
- Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, USA
- Boston Medical Center Department of Otolaryngology, Boston, Massachusetts, USA
| |
Collapse
|
15
|
Pranić SM, Estevão MD, Vasanthan LT, Pérez-Neri I, Pulumati A, de Lima Junior FAS, Malih N, Mishra V, Thompson J, Nnate D. Reporting of participant race and ethnicity from COVID-19 randomized controlled drug and biologicals trials: a scoping review. Epidemiol Rev 2025; 47:1-14. [PMID: 39673248 DOI: 10.1093/epirev/mxae006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2022] [Revised: 07/10/2024] [Accepted: 11/26/2024] [Indexed: 12/16/2024] Open
Abstract
Racial and ethnic minorities have been disproportionally burdened by hospitalization and death due to COVID-19. Participation of individuals of diverse races and ethnicities in clinical trials, according to study-level characteristics of randomized controlled trials (RCTs) that test effectiveness of COVID-19 drugs, could be insightful for future researchers. Our objective for this scoping review was to describe the frequency of race and ethnicity reported as demographic variables and specific reporting of race and ethnicity according to COVID-19 RCT characteristics. We conducted comprehensive searches in PubMed, ProQuest, World Health Organization Database, and Cochrane Central Register of Controlled Trials, and gray literature via preprint servers from January 1, 2020, to May 4, 2022. We included RCTs on emergency- or conditionally approved COVID-19 drug interventions (remdesivir, baricitinib, and molnupiravir) with or without comparators. Self-reported race as American Indian/Pacific Islander, Asian, Black/African American, or White, ethnicity as Hispanic/Latinx, study design characteristics, and participant-relevant data were collected. In total, 17 RCTs with 17 935 participants were included. Most (n = 13; 76%) reported at least 1 race and ethnicity and were US-based, industry-funded RCTs. Asian, Black, Latinx, and White participants were mostly enrolled in RCTs that studied remdesivir. Native American and Hawaiian participants were mostly assessed for progression to high-flow oxygen/noninvasive ventilation. Time to recovery was assessed predominantly in Black and White participants, whereas hospitalization or death was mostly assessed in Asian, Latinx, and multirace participants. Trialists should be aware of RCT-level factors and characteristics that may be associated with low participation of racial and ethnic minorities, which could inform evidence-based interventions to increase minority participation.
Collapse
Affiliation(s)
- Shelly Melissa Pranić
- Department of Public Health, University of Split School of Medicine, 21000 Split, Croatia
- Cochrane Croatia, 21000 Split, Croatia
| | - Maria Dulce Estevão
- School of Health, University of Algarve, Faro, Faro District, 8005-139, Portugal
| | - Lenny T Vasanthan
- Physiotherapy Unit, Physical Medicine and Rehabilitation Department, Christian Medical College, Vellore, 632004, India
| | - Iván Pérez-Neri
- Department of Neurochemistry, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez, Insurgentes Sur 3877, La Fama, Tlalpan, 14269, Ciudad de México, Mexico
| | - Anika Pulumati
- University of Missouri-Kansas City School of Medicine, Kansas City, MO, United States
| | - Fábio Antonio Serra de Lima Junior
- Centro de Ciências Médicas, Universidade Federal da Paraíba (Federal University of Paraíba), João Pessoa, Castelo Branco, PB, 58051-900, Brazil
| | - Narges Malih
- Global Health Research Group, University of the Balearic Islands, 07122 Palma, Spain
- Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, 1983969411 Tehran, Iran
| | - Vinayak Mishra
- University of Liverpool, Liverpool, L69 7ZX, United Kingdom
| | | | - Daniel Nnate
- University of Liverpool, Liverpool, L69 7ZX, United Kingdom
| |
Collapse
|
16
|
Arthurs L, Fredericks S, Attlassy Y, Raghunathan R, Alam IS, Allendorf J, Rothberger G, Prescott J, Patel KN, Suh I. Language-based exclusion associations with racial and ethnic disparities in thyroid cancer clinical trials. Surgery 2025; 177:108826. [PMID: 39379255 DOI: 10.1016/j.surg.2024.07.073] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/11/2024] [Revised: 06/30/2024] [Accepted: 07/02/2024] [Indexed: 10/10/2024]
Abstract
BACKGROUND Racial and ethnic disparities in thyroid cancer care may be mitigated by improving enrollment of more diverse patient populations in clinical trials. We studied trial eligibility criteria and enrollment to assess barriers to equitable representation. METHODS ClinicalTrials.gov was searched for studies on thyroid cancer treatment conducted between 1993 and 2023. The inclusion and exclusion criteria of each study were examined. For published studies, reported demographic information was collected. Observed enrollment by race was compared with the expected distribution as determined using data from the US Census and the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) databases. Over- and under-representation was defined as the ratio of observed to expected (O/E) enrollment by the race and ethnicity group. RESULTS Of 309 thyroid cancer-related trials, 23 (7.4%) used language as an exclusion criterion. Most were interventional (n = 239, 77.3%), university-initiated (194, 62.8%), and drug/device-focused (195, 63.1%). Of studies that excluded by language, 20 (87.0%) were university-initiated. Eighty-eight trials were subsequently published, with 16 (18.2%) reporting race and/or ethnicity distributions. When comparing O/E ratios, White American participants were over-represented (O/E ratio: 1.2, P < .0001). Under-represented groups included Asian/Native Hawaiian (O/E ratio: 0.6, P = .0085), Black (0.6, P = .014), Native American (0.2, P = .072), and Hispanic patients (0.2, P < .0001). CONCLUSION Over the last 3 decades, 1 in 13 thyroid cancer-related clinical trials excluded patients based on language. In the fraction of published studies to report on racial and ethnic demographics, Asian/Native Hawaiian, Black, and Hispanic patients were under-represented. Improved reporting of demographics in published studies and elimination of exclusion criteria such as language that hinder enrollment of minority patients could improve equitable representation of patients in thyroid cancer clinical trials.
Collapse
Affiliation(s)
- Likolani Arthurs
- Department of Surgery, New York University Grossman School of Medicine and NYU Langone Health, New York, NY
| | | | | | - Rajam Raghunathan
- Department of Surgery, New York University Grossman School of Medicine and NYU Langone Health, New York, NY
| | - Iram S Alam
- Department of Surgery, New York University Grossman School of Medicine and NYU Langone Health, New York, NY
| | - John Allendorf
- Department of Surgery, New York University Grossman School of Medicine and NYU Langone Health, New York, NY
| | - Gary Rothberger
- Department of Surgery, New York University Grossman School of Medicine and NYU Langone Health, New York, NY
| | - Jason Prescott
- Department of Surgery, New York University Grossman School of Medicine and NYU Langone Health, New York, NY
| | - Kepal N Patel
- Department of Surgery, New York University Grossman School of Medicine and NYU Langone Health, New York, NY
| | - Insoo Suh
- Department of Surgery, New York University Grossman School of Medicine and NYU Langone Health, New York, NY.
| |
Collapse
|
17
|
Hanvey GA, Johnson H, Cartagena G, Dede DE, Krieger JL, Ross KM, Pereira DB. The role of social, economic, and medical marginalization in cancer clinical trial participation inequities: A systematic review. J Clin Transl Sci 2024; 9:e25. [PMID: 40052046 PMCID: PMC11883616 DOI: 10.1017/cts.2024.677] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/16/2024] [Revised: 11/24/2024] [Accepted: 12/02/2024] [Indexed: 03/09/2025] Open
Abstract
Extant literature reveals how patients of marginalized social identities, socioeconomic status (SES), and medical experiences - especially patients of color and older adults - are underrepresented in cancer clinical trials (CCTs). Emerging evidence increasingly indicates CCT underrepresentation among patients of lower SES or rural origin, sexual and gender minorities, and patients with comorbid disability. This review applies an intersectional perspective to characterizing CCT representativeness across race and ethnicity, age, sexual and gender identity, SES, and disability. Four databases were systematically queried for articles addressing CCT participation inequities across these marginalizing indicators, using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. One hundred one articles were included in a qualitative evaluation of CCT representativeness within each target population in the context of their intersectional impacts on participation. Findings corroborate strong evidence of CCT underrepresentation among patients of color, older age, lower SES, rural origin, and comorbid disabling conditions while highlighting systemic limitations in data available to characterize representativeness. Results emphasize how observed inequities interactively manifest through the compounding effects of minoritized social identity, inequitable economic conditions, and marginalizing medical experiences. Recommendations are discussed to more accurately quantify CCT participation inequities across underserved cancer populations and understand their underpinning mechanisms.
Collapse
Affiliation(s)
- Grace Ann Hanvey
- University of Florida, Department of Clinical and Health Psychology, Gainesville, FL, USA
| | - Hannah Johnson
- University of Florida, Department of Clinical and Health Psychology, Gainesville, FL, USA
| | | | - Duane E. Dede
- University of Florida, Department of Clinical and Health Psychology, Gainesville, FL, USA
| | | | - Kathryn M. Ross
- University of Florida, Department of Clinical and Health Psychology, Gainesville, FL, USA
| | - Deidre B. Pereira
- University of Florida, Department of Clinical and Health Psychology, Gainesville, FL, USA
| |
Collapse
|
18
|
Islam N, Budvytyte L, Khera N, Hilal T. Disparities in Clinical Trial Enrollment- Focus on CAR-T and Bispecific Antibody Therapies. Curr Hematol Malig Rep 2024; 20:1. [PMID: 39630328 PMCID: PMC11618314 DOI: 10.1007/s11899-024-00747-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 09/30/2024] [Indexed: 12/08/2024]
Abstract
PURPOSE OF REVIEW Recent studies show that unresolved disparities hinder enrollment to clinical trials, equitable distribution of treatments, and impact the generalizability of trials, compromising health outcomes across different populations. This review aims to examine the persistent disparities noted in clinical trial enrollment, with particular focus on lymphoid malignancies, CAR-T cell and bispecific antibody therapies. RECENT FINDINGS Targeted interventions can enhance recruitment of underrepresented groups in clinical trials and address the complex barriers hindering participation, which are essential for achieving healthcare access equity and treatment outcomes. Improvement must be multifaceted, addressing socioeconomic, geographic, and biologic factors contributing to underrepresentation. This includes more lenient eligibility criteria, improving outreach and education, as well as using technology to diversify trial participation.
Collapse
Affiliation(s)
- Nadia Islam
- Mayo Clinic Alix School of Medicine, Scottsdale, AZ, 85254, USA
| | - Laura Budvytyte
- Mayo Clinic Alix School of Medicine, Scottsdale, AZ, 85254, USA
| | - Nandita Khera
- Division of Hematology/Oncology, Mayo Clinic, 5777 E. Mayo Blvd, Phoenix, AZ, 85054, USA
| | - Talal Hilal
- Division of Hematology/Oncology, Mayo Clinic, 5777 E. Mayo Blvd, Phoenix, AZ, 85054, USA.
| |
Collapse
|
19
|
Ma C, Shulman DS, Al-Sayegh H, DuBois SG, London WB. Targeted-Agent Continual Reassessment Method: A Novel Bayesian Enrichment Design for Phase I Trials of Molecularly Targeted Therapies. JCO Precis Oncol 2024; 8:e2400360. [PMID: 39715485 PMCID: PMC11670905 DOI: 10.1200/po.24.00360] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/29/2024] [Revised: 09/20/2024] [Accepted: 11/05/2024] [Indexed: 12/25/2024] Open
Abstract
PURPOSE Novel therapies targeting specific genomic alterations are a promising treatment approach for relapsed/refractory cancer. Patients with specific alterations may be more likely to respond. Trial designs should maximize opportunities for such patients to enroll on these trials. Existing designs do not enrich for patients with specific alterations. We developed the adaptive Targeted Agent-Continual Reassessment Method (TARGET-CRM) to optimize dose finding and enrich for patients with specific alterations, and applied it in a pediatric phase I trial. METHODS Patients were stratified to cohort A (unspecified tumors) or cohort B (rare genomic alterations). The TARGET-CRM design permits cohort B patients to immediately enroll at one dose level below the currently evaluated dose level instead of waiting for an open slot at the current dose level. Using simulations, we compared the operating characteristics (accuracy-the proportion of trials in which the true maximum tolerated dose [MTD] was identified/recommended; safety-the dose-limiting toxicity [DLT] rate; the proportion of cohort B patients enrolled) of the TARGET-CRM, standard CRM, and 3 + 3 designs across various scenarios. RESULTS The proportion of enrolled patients who were cohort B was higher for TARGET-CRM (90%-100%) compared with CRM (approximately 85%) and 3 + 3 (approximately 79%). The DLT rate and rate the true MTD was recommended were similar for TARGET-CRM and CRM, differing by only 0%-4% and 0%-4%, respectively. Results were similar regardless of trial sample size and proportion of cohort B patients in the population. CONCLUSION In phase I dose-finding trials of targeted agents, the Bayesian adaptive TARGET-CRM design maximizes enrollment of patients hypothesized as most likely to benefit from the targeted agent, while maintaining similar or superior accuracy and safety as the CRM and 3 + 3 designs.
Collapse
Affiliation(s)
- Clement Ma
- Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA
- Harvard Medical School, Boston, MA
| | - David S. Shulman
- Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA
- Harvard Medical School, Boston, MA
| | - Hasan Al-Sayegh
- Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA
| | - Steven G. DuBois
- Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA
- Harvard Medical School, Boston, MA
| | - Wendy B. London
- Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA
- Harvard Medical School, Boston, MA
| |
Collapse
|
20
|
Halley MC, Olson NW, Ashley EA, Goldenberg AJ, Tabor HK. A Just Genomics Needs an ELSI of Translation. Hastings Cent Rep 2024; 54 Suppl 2:S126-S135. [PMID: 39707956 PMCID: PMC11801241 DOI: 10.1002/hast.4938] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2024]
Abstract
The rapid advances in genomics over the last decade have come to fruition amid intense public discussions of justice in medicine and health care. While much emphasis has been placed on increasing diversity in genomics research participation, an overly narrow focus on recruitment eschews recognition of the disparities in health care that will ultimately shape access to the benefits of genomic medicine. In this essay, we suggest that achieving a just genomics, both now and in the future, requires an explicit ELSI of translation-normative and pragmatic scholarship that embraces the interconnectedness of research and clinical care and centers the obligations of researchers, institutions, and funders to mitigate inequities throughout the translational pipeline. We propose core principles to guide an ELSI of translation and to ensure that this work balances the value of the generalizable knowledge that genomics research generates and the value of the individuals and communities who make this research possible.
Collapse
|
21
|
Milinic T, Burdis N, Gill E, Burks P, Jarosz ME, Hoffman AJ, Kapnadak SG, Ramos KJ, Goss CH. Research Coordinators' Perspectives on Recruitment of Minoritized People with Cystic Fibrosis into Clinical Trials. RESEARCH SQUARE 2024:rs.3.rs-5195002. [PMID: 39606463 PMCID: PMC11601850 DOI: 10.21203/rs.3.rs-5195002/v1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/29/2024]
Abstract
Background Clinical trials in cystic fibrosis (CF) disproportionately over-represent non-Hispanic, White individuals. Barriers and facilitators to enrolling racially and ethnically minoritized individuals with CF are not well understood. This study explored research coordinator (RC) perspectives on recruitment and enrollment of minoritized people with CF (PwCF) into clinical trials. Methods A cross-sectional survey was administered to RCs in the CF Therapeutics Development Network (CF TDN), eliciting perceived barriers and facilitators to inclusion of minoritized PwCF in clinical research. Respondents were categorized based on their self-reported experience discussing and successfully enrolling minoritized PwCF into clinical trials. Results Among 48 respondents, the majority (n = 31, 64%) had little to no experience discussing CF clinical trials with minoritized PwCF. Respondents who had a moderate or great deal of experience identified that having a trusted clinical team member first introduce the study to PwCF as the most common strategy for recruitment. Experienced respondents also identified the importance of having team members who speak the same language or are the same culture as the minoritized PwCF. Respondents who had little to no experience successfully enrolling minoritized PwCF into clinical trials cited low numbers of minoritized patients at their study center as an important consideration. All respondents emphasized language barriers in enrollment including need for adequate translation services and printed materials in the PwCF's primary language. Conclusion Our study identified modifiable barriers that may be addressed at the level of trial design and study center.
Collapse
|
22
|
Aninye IO. A call for inclusive research, policies, and leadership to close the global women's health gap. Biol Sex Differ 2024; 15:91. [PMID: 39516838 PMCID: PMC11546066 DOI: 10.1186/s13293-024-00669-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2024] Open
Abstract
Women comprise approximately half of the world's population, yet they are often underrepresented and inadequately considered in medical and public health research and in health care delivery in the United States and around the world. Elucidating sex and gender differences in disease and fundamental hormonal drivers of women's health is instrumental to informing our overall understanding of human health and improving women's health outcomes across the lifespan. The Society for Women's Health Research and ECH Alliance-The Global Health Connector hosted a women's health program as part of the United Nations 79th General Assembly Science Summit. Here, I briefly describe the basis for this convening to address global gender health gaps and reflect on the event's presentations and discussions to recognize and better integrate women's unique health needs in the sustainable development goals.
Collapse
Affiliation(s)
- Irene O Aninye
- Society for Women's Health Research, Washington, DC, 20036, USA.
| |
Collapse
|
23
|
Baig Mirza A, Fayez F, Rashed S, Burn L, Evans ZM, Karagozlu Z, Vastani A, Lavrador JP, Vergani F, Gullan R, Bhangoo R, Ashkan K. Ethnicity in neuro-oncology research: How are we doing and how can we do better? J Neurooncol 2024; 170:223-233. [PMID: 39316318 PMCID: PMC11538236 DOI: 10.1007/s11060-024-04769-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/09/2024] [Accepted: 07/03/2024] [Indexed: 09/25/2024]
Abstract
PURPOSE This study systematically reviews and meta-analyses the extent of ethnic minority representation in neuro-oncology Phase III and IV clinical trials, explores the effect of ethnicity on outcomes, and identifies predictors for the inclusion of ethnicity data in publications. METHODS Adhering to PRISMA guidelines, we conducted a comprehensive literature search across multiple databases, on Phase III and IV trials in neuro-oncology that reported on adult and/or paediatric subjects. Through meta-analysis, we synthesized information on overall survival, event-free survival, and the incidence of adverse outcomes across ethnicities. RESULTS From 448 identified articles, a fraction reported ethnicity data, with an even smaller number providing outcome data stratified by ethnicity. Most study participants were identified as White, underscoring a significant underrepresentation of minorities. Our meta-analysis did not reveal significant outcome differences by ethnicity, which may be attributed to the limited and inadequate reporting of data. Predictors for including ethnicity data were identified, including trials in North America(OR2.39, 95%CI 1.18-5.12, p < 0.02),trials of drugs or biologic agents(OR 5.28, 95%CI 1.43-3.42, p < 0.05),and trials funded by charities(OR 2.28, 95% CI 1.04-5.27, p < 0.05) or pharmaceutical companies(OR 3.98, 95% CI 1.60-10.0, p < 0.005). CONCLUSION The underrepresentation of minorities in neuro-oncology clinical trials and the inadequately characterized impact of ethnicity on treatment outcomes highlight a critical need for more inclusive recruitment strategies and improved reporting standards. Change is necessary to ensure trials reflect the diversity of the patient population, which is essential for developing tailored strategies and improving outcomes. Future research should prioritize understanding the role of ethnicity in neuro-oncology to facilitate personalized treatment approaches.
Collapse
Affiliation(s)
- Asfand Baig Mirza
- Department of Neurosurgery, Kings College Hospital, Denmark Hill, London, SE5 9RS, UK.
- Department of Neurosurgery, Queens Hospital Romford, Romford, UK.
| | - Feras Fayez
- Imperial College Healthcare Trust, London, UK
| | - Sami Rashed
- Department of Neurosurgery, Queens Hospital Romford, Romford, UK
| | - Layla Burn
- Barts and The London School of Medicine and Dentistry, London, UK
| | | | | | - Amisha Vastani
- Department of Neurosurgery, St George's Hospital, St George's University Hospitals NHS Foundation Trust, London, UK
| | - Jose Pedro Lavrador
- Department of Neurosurgery, Kings College Hospital, Denmark Hill, London, SE5 9RS, UK
| | - Francesco Vergani
- Department of Neurosurgery, Kings College Hospital, Denmark Hill, London, SE5 9RS, UK
| | - Richard Gullan
- Department of Neurosurgery, Kings College Hospital, Denmark Hill, London, SE5 9RS, UK
| | - Ranjeev Bhangoo
- Department of Neurosurgery, Kings College Hospital, Denmark Hill, London, SE5 9RS, UK
| | - Keyoumars Ashkan
- Department of Neurosurgery, Kings College Hospital, Denmark Hill, London, SE5 9RS, UK
| |
Collapse
|
24
|
Lindo S, Roberts J, Goodrich J, Mella-Velazquez A, Musty MD, Cheng AC, Kost RG, Gonzalez-Guarda RM, Chatterjee R. Fielding the research participant perception survey to evaluate a culturally tailored Latinx cohort study. J Clin Transl Sci 2024; 8:e178. [PMID: 39655014 PMCID: PMC11626567 DOI: 10.1017/cts.2024.629] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/07/2024] [Revised: 09/13/2024] [Accepted: 09/24/2024] [Indexed: 12/12/2024] Open
Abstract
Introduction Latinx populations are underrepresented in clinical research. Asking Latinx research participants about their research experiences, barriers, and facilitators could help to improve research participation for these populations. Methods The Salud Estres y Resilencia (SER) Hispano cohort study is a longitudinal cohort study of young adult Latinx immigrants whose design and conduct were tailored for their study population. We administered the Research Participant Perception Survey (RPPS) to SER Hispano participants to assess their experiences in the study. We describe overall results from the RPPS and compare results of surveys administered to SER Hispano participants via email versus telephone. Results Of 340 participants who were contacted with the RPPS, 142 (42%) responded. Among respondents, 53 (37%) responded by initial email contact; and 89 (63%) responded by subsequent phone contact. The majority of respondents were between 35 and 44 years of age (54%), female (76%), and of Cuban origin (50%). Overall, research participants expressed high satisfaction with their research experience; 84% stated that they would "definitely" recommend research participation to friends and family, with no significant difference by method of survey administration (P = 0.45). The most common factor that was chosen that would influence future research participation was having summary results of the research shared with them (72%). Conclusion We found that culturally tailored studies can be good experiences for Latinx research participants; and we found that use of the RPPS can be administered successfully, particularly when administered by more than one method, including telephone, to evaluate and to improve research experiences for this population.
Collapse
Affiliation(s)
- Sierra Lindo
- Duke Clinical and Translational Science Institute, Recruitment Innovation Center, Duke University, Durham, NC, USA
| | - Jamie Roberts
- Duke Cancer Institute, Duke University, Durham, NC, USA
| | - James Goodrich
- Duke Psychiatry & Behavioral Sciences, Duke University, Durham, NC, USA
| | | | - Michael D. Musty
- Duke Clinical and Translational Science Institute, Recruitment Innovation Center, Duke University, Durham, NC, USA
| | - Alex C. Cheng
- Department of Biomedical Informatics, Vanderbilt University, Nashville, TN, USA
| | - Rhonda G. Kost
- Center for Clinical and Translational Science, The Rockefeller University, New York, NY, USA
| | | | - Ranee Chatterjee
- Duke Clinical and Translational Science Institute, Recruitment Innovation Center, Duke University, Durham, NC, USA
- Duke University School of Medicine, Durham, NC, USA
| |
Collapse
|
25
|
Shin E, Ravichandran C, Renzi D, Pober BR, McDougle CJ, Thom RP. Diversity of Participants in Williams Syndrome Intervention Studies. J Autism Dev Disord 2024; 54:3888-3898. [PMID: 37584767 DOI: 10.1007/s10803-023-06088-2] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/30/2023] [Indexed: 08/17/2023]
Abstract
PURPOSE This study describes participant diversity in Williams syndrome (WS) intervention studies. METHODS A literature search was conducted to identify prospective treatment studies including participants with WS. Data was extracted on the reporting of and information provided on age, sex, cognitive ability, socioeconomic status, race, and ethnicity. RESULTS Eleven eligible articles were identified. Reporting rates of demographic factors varied considerably, with the highest rates for age and sex (100%) and the lowest reporting rates for race (18%) and ethnicity (9%). Combining demographic data from the two studies that reported on race and/or ethnicity (n = 33), 88% of participants were White. The combined participant mean age was 20.9 years. CONCLUSION There is a low frequency of reporting on several demographic factors including socioeconomic status, race, and ethnicity in WS intervention studies. There is a need for increased representation of racial and ethnic minority groups, older participants, and more cognitively impaired patients in WS research.
Collapse
Affiliation(s)
- Eva Shin
- Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA
- Haverford College, Haverford, PA, USA
| | - Caitlin Ravichandran
- Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA
- McLean Hospital, Belmont, MA, USA
- Massachusetts General Hospital, Boston, MA, USA
- Department of Psychiatry, Harvard Medical School, Boston, MA, USA
| | - Danielle Renzi
- Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA
- Massachusetts General Hospital, Boston, MA, USA
| | - Barbara R Pober
- Massachusetts General Hospital, Boston, MA, USA
- Department of Pediatrics, Harvard Medical School, Boston, MA, USA
| | - Christopher J McDougle
- Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA
- Massachusetts General Hospital, Boston, MA, USA
- Department of Psychiatry, Harvard Medical School, Boston, MA, USA
| | - Robyn P Thom
- Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA.
- Massachusetts General Hospital, Boston, MA, USA.
- Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
| |
Collapse
|
26
|
Shusted CS, Barta JA, Nguyen A, Wen KY, Juon HS, Zeigler-Johnson C. Characterizing Lung Cancer Burden Among Asian-American Communities in Philadelphia. J Racial Ethn Health Disparities 2024; 11:2583-2595. [PMID: 37540304 DOI: 10.1007/s40615-023-01723-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/16/2022] [Revised: 06/08/2023] [Accepted: 07/06/2023] [Indexed: 08/05/2023]
Abstract
Lung cancer (LC) is the leading cause of cancer death among Asian-Americans. However, there are differences in LC incidence and mortality among Asian racial subgroups. The objective of this study was to describe LC burden and disparities among race/ethnic groups (White, Black, Asian, and Hispanic) across US census tracts (CT) in Philadelphia using the Pennsylvania Cancer Registry dataset (N=11,865). ArcGIS Pro was used to geocode patient addresses to the CT level for linkage to US Census data. Despite being diagnosed more frequently with advanced-stage lung cancer compared with other race and ethnic groups in Philadelphia, Asian patients were most likely to be alive at the time of data receipt. Among Asian subgroups, Korean patients were the oldest (median age 75, p=0.024). Although not statistically different, distant stage disease was the most prevalent among Asian Indian (77.8%) and Korean (73.7%) and the least prevalent among Chinese patients (49.5%). LC was the cause of death for 77.8% of Asian Indian, 63.2% of Korean, 52.9% of other Asian, 48.5% of Chinese, and 47.5% of Vietnamese patients. CTs where Asian individuals were concentrated had lower socioeconomic status and greater tobacco retailer density compared to the entire city. Compared to all of Philadelphia, heavily Asian CTs experienced a greater age-standardized LC incidence (1.48 vs. 1.42) but lower age-standardized LC mortality (1.13 vs. 1.22). Our study suggests that LC disparities exist among Asian subgroups, with Asian Indian and Korean Philadelphians most likely to present with advanced disease. Additional studies are needed to investigate LC among high-risk racial and ethnic groups, including Asian subgroups.
Collapse
Affiliation(s)
- Christine S Shusted
- Division of Pulmonary and Critical Care Medicine, The Jane and Leonard Korman Respiratory Institute at Thomas Jefferson University, Philadelphia, PA, USA
| | - Julie A Barta
- Division of Pulmonary and Critical Care Medicine, The Jane and Leonard Korman Respiratory Institute at Thomas Jefferson University, Philadelphia, PA, USA
| | - Anh Nguyen
- Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA
| | - Kuang-Yi Wen
- Division of Population Science, Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, USA
| | - Hee-Soon Juon
- Division of Population Science, Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, USA
| | - Charnita Zeigler-Johnson
- Fox Chase Cancer Center, Cancer Prevention and Control, 4141 Young Pavilion, 333 Cottman Avenue, Philadelphia, PA, USA.
| |
Collapse
|
27
|
Lee YW, Wang V, Wang MJ, Kim KH. The effects of Asian American Pacific Islander (AAPI) data inequities in gynecologic oncology. Gynecol Oncol 2024; 189:64-67. [PMID: 39029275 DOI: 10.1016/j.ygyno.2024.06.022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/19/2024] [Revised: 06/25/2024] [Accepted: 06/25/2024] [Indexed: 07/21/2024]
Abstract
Asian American and Pacific Islanders (AAPI) are the fastest growing racial group in the United States. Data on AAPI communities, however, are significantly limited. The oversimplification and underreporting of this ethnically and socioeconomically heterogenous population through the use of aggregated data has deleterious effects and worsens disparities in patient treatment, outcomes, and experiences. Gynecologic oncology disparities do not exist in a vacuum, and are rooted in larger cultural gaps in our understanding and delivery of healthcare. In this paper, we aim to demonstrate how AAPI data inequities have negative downstream effects on research and public health policies and initiatives, and also provide a call to action with specific recommendations on how to improve AAPI data equity within these realms.
Collapse
Affiliation(s)
- Yeon Woo Lee
- Division of Gynecologic Oncology, Department of OB/GYN and Reproductive Sciences, University of California San Francisco, 490 Illinois St. Floor 10, Box 0132, San Francisco, CA 94143, USA.
| | - Victoria Wang
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, USA
| | - Michelle J Wang
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, 330 Brookline Ave., Boston, MA 02215, USA
| | - Kenneth H Kim
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, 8635 W. 3(rd) St., Suite 290W, Los Angeles, CA 90048, USA
| |
Collapse
|
28
|
Schpero WL, Takvorian SU, Blickstein D, Shafquat A, Liu J, Chatterjee AK, Lamont EB, Chatterjee P. Association Between State Medicaid Policies and Accrual of Black or Hispanic Patients to Cancer Clinical Trials. J Clin Oncol 2024; 42:3238-3246. [PMID: 39052944 PMCID: PMC11408099 DOI: 10.1200/jco.23.01149] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/26/2023] [Revised: 04/14/2024] [Accepted: 05/10/2024] [Indexed: 07/27/2024] Open
Abstract
PURPOSE It is unknown whether Medicaid expansion under the Affordable Care Act (ACA) or state-level policies mandating Medicaid coverage of the routine costs of clinical trial participation have ameliorated longstanding racial and ethnic disparities in cancer clinical trial enrollment. METHODS We conducted a retrospective, cross-sectional difference-in-differences analysis examining the effect of Medicaid expansion on rates of enrollment for Black or Hispanic nonelderly adults in nonobservational, US cancer clinical trials using data from Medidata's Rave platform for 2012-2019. We examined heterogeneity in this effect on the basis of whether states had pre-existing mandates requiring Medicaid coverage of the routine costs of clinical trial participation. RESULTS The study included 47,870 participants across 1,353 clinical trials and 344 clinical trial sites. In expansion states, the proportion of participants who were Black or Hispanic increased from 16.7% before expansion to 17.2% after Medicaid expansion (0.5 percentage point [PP] change [95% CI, -1.1 to 2.0]). In nonexpansion states, this proportion increased from 19.8% before 2014 (when the first states expanded eligibility under the ACA) to 20.4% after 2014 (0.6 PP change [95% CI, -2.3 to 3.5]). These trends yielded a nonsignificant difference-in-differences estimate of 0.9 PP (95% CI, -2.6 to 4.4). Medicaid expansion was associated with a 5.3 PP (95% CI, 1.9 to 8.7) increase in the enrollment of Black or Hispanic participants in states with mandates requiring Medicaid coverage of the routine costs of trial participation, but not in states without mandates (-0.3 PP [95% CI, -4.5 to 3.9]). CONCLUSION Medicaid expansion was not associated with a significant increase in the proportion of Black or Hispanic oncology trial participants overall, but was associated with an increase specifically in states that mandated Medicaid coverage of the routine costs of trial participation.
Collapse
Affiliation(s)
- William L. Schpero
- Division of Health Policy and Economics, Department of Population Health Sciences, Weill Medical College; and Center for Health Equity, Cornell University, New York, NY
| | - Samuel U. Takvorian
- Division of Hematology and Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
- Department of Medicine, Perelman School of Medicine; and Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA
| | | | | | - Jingshu Liu
- Medidata AI, a Dassault Systèmes Company, New York, NY
| | | | | | - Paula Chatterjee
- Department of Medicine, Perelman School of Medicine; and Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA
| |
Collapse
|
29
|
Gutnick DN, Lozano P, Rodriguez Martinez S, Wang KW, Williams DA, Rapkin BD, Gonzalez-Lepage N. Research protocol for bridging research, accurate information and dialogue (BRAID)-clinical trials: a mixed-methods study of a community-based intervention to improve trust and diversify participation in clinical trials. Front Public Health 2024; 12:1407726. [PMID: 39351035 PMCID: PMC11439785 DOI: 10.3389/fpubh.2024.1407726] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/27/2024] [Accepted: 08/13/2024] [Indexed: 10/04/2024] Open
Abstract
Cultural beliefs, personal experiences, and historic abuses within the healthcare system-rooted in structural racism-all contribute to community distrust in science and medicine. This lack of trust, particularly within underserved communities, contributes to decreased participation in clinical trials and a lack of representation in the data. Open dialogue about community concerns and experiences related to research participation and medical care processes can help build trust and change attitudes and behaviors that affect community health. This protocol outlines an approach to increase trust in science and clinical trials among communities in the Bronx, New York that are typically underrepresented in research data. Bridging Research, Accurate Information and Dialogue (BRAID) is a two-phased, evidence-based community engagement model that creates safe spaces for bilateral dialogues between trusted community messengers, and clinicians and scientists. The team will conduct a series of BRAID Conversation Circles on the topic of clinical trials with local trusted community messengers. Participants will be members of the community who are perceived as "trusted messengers" and can represent the community's voice because they have insight into "what matters" locally. Conversation Circles will be audiotaped, transcribed, and analyzed to identify emergent challenges and opportunities surrounding clinical trial participation. These key themes will subsequently inform the codesign and co-creation of tailored messages and outreach efforts that community participants can disseminate downstream to their social networks. Surveys will be administered to all participants before and after each Conversation Circle to understand participants experience and evaluate changes in knowledge and attitudes about clinical trials, including protections for research participants the advantages of having diverse representation. Changes in motivation and readiness to share accurate clinical trial information downstream will also be assessed. Lastly, we will measure participants dissemination of codesigned science messages through their social networks by tracking participant specific resource URLs of materials and videos posted on a BRAID website. This protocol will assess the effectiveness and adoptability of an innovative CBPR model that can be applied to a wide range of public health issues and has the potential to navigate the ever-changing needs of the communities that surround health systems.
Collapse
Affiliation(s)
- Damara N. Gutnick
- Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, United States
- Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, NY, United States
- Department of and Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Bronx, NY, United States
- Insititute for Clinical and Translational Research, Albert Einstein College of Medicine, Bronx, NY, United States
- Office of Community and Population Health, Montefiore Medical Center, Bronx, NY, United States
| | - Patricia Lozano
- Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, United States
| | - Smeily Rodriguez Martinez
- Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, United States
| | - Katherine W. Wang
- Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, United States
| | - Debra A. Williams
- Office of Community and Population Health, Montefiore Medical Center, Bronx, NY, United States
| | - Bruce D. Rapkin
- Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, United States
| | - Nelly Gonzalez-Lepage
- Department of Child and Adolescent Psychiatry, NYU Langone Medical Center, New York, NY, United States
- NYC Health + Hospitals/Bellevue Hospital, New York, NY, United States
| |
Collapse
|
30
|
Samimi G, Temkin SM, Weil CJ, Han PK, LeeVan E, Rubinstein WS, Swigart T, Caban S, Dent K, Minasian LM. Primary care physicians and laypersons' perceptions of multicancer detection clinical trial designs. JNCI Cancer Spectr 2024; 8:pkae084. [PMID: 39270066 PMCID: PMC11463188 DOI: 10.1093/jncics/pkae084] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2024] [Revised: 08/06/2024] [Accepted: 09/09/2024] [Indexed: 09/15/2024] Open
Abstract
BACKGROUND The National Cancer Institute Cancer Screening Research Network is launching a pilot study (Vanguard) to determine feasibility of successful completion of a clinical trial of multicancer detection tests. This focus group study reports perceptions of primary care physicians and laypersons of different clinical trial designs and willingness to participate in a multicancer detection clinical trial. METHODS We undertook 14 focus groups with 88 laypersons and 6 focus groups with 45 primary care physicians. Participants were shown graphics of clinical trial designs and asked for their reactions. Focus group recordings were transcribed verbatim, and thematic analysis of the transcripts were conducted to identify emergent themes. RESULTS Primary care physician and layperson participants recognized the importance of conducting clinical trials to determine the clinical utility of multicancer detection tests. Primary care physicians expressed reluctance to participate in trials because of workload burden, and laypersons expressed hesitancy about enrolling in the control group. Primary care physicians and laypersons expressed concern about a study design in which multicancer detection test results would not be returned to the control group (intended effect), but they respectively indicated a willingness to refer patients to, or participate in, a multicancer detection test clinical trial given transparent and clear communication on collection and use of biospecimens and data, particularly if a multicancer detection test would eventually be run and results eventually returned. CONCLUSION This study yielded important insights to guide trial design in planning prospective evaluation of multicancer detection testing. Maintaining transparency and trust while possibly withholding multicancer detection test results to maximize trial feasibility and efficiency is of particular concern.
Collapse
Affiliation(s)
- Goli Samimi
- Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
| | - Sarah M Temkin
- Office of Research on Women’s Health, National Institutes of Health, Bethesda, MD, USA
| | - Carol J Weil
- Human Research Protections and Bioethics, Independent Consultant, Bethesda, MD, USA
| | - Paul K Han
- Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA
| | - Elyse LeeVan
- Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
| | - Wendy S Rubinstein
- Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
| | | | | | | | - Lori M Minasian
- Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA
| |
Collapse
|
31
|
Ison JM, Jackson JD, Hemley H, Willis A, Siddiqi B, Macklin EA, Ulysse C, Fitts MS, Pham TTH, Afshari M, Agarwal P, Aminoff M, Bissonnette S, Fullard M, Khan TS, Larson DN, Wielinski C, Sanchez AV. Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson's Disease: The FIRE-UP PD study. Contemp Clin Trials 2024; 144:107619. [PMID: 38971301 DOI: 10.1016/j.cct.2024.107619] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2024] [Revised: 06/28/2024] [Accepted: 07/03/2024] [Indexed: 07/08/2024]
Abstract
BACKGROUND Members of vulnerable populations are underrepresented in Parkinson's disease (PD) research. A complex web of research barriers perpetuates this gap. Community-based research methods are one approach to addressing this issue. The present PD study was designed to examine the effectiveness of community-based interventions to overcome barriers and increase research participation among underrepresented groups (URGs). METHODS Eight study sites across the US were selected and paired based on proposed interventions with specific URGs. Surveys assessed knowledge and attitudes toward PD research. Finally, researchers examined whether the present study affected recruitment to Fox Insight, an online PD research study also recruiting at each site. RESULTS In total, 474 participants were recruited. At post-intervention for the FIRE-UP PD Study, recruitment increased significantly in intervention compared to control sites among Black and African American non-Hispanic/Latino populations (p = 0.003), White Hispanic/Latino (p = 0.003) populations, and Not Listed Hispanic/Latino populations (p < 0.001) as well as those with an educational attainment of a high school diploma/General Education Diploma (GED) (p = 0.009), and an income <$20,000 (p = 0.005) or between $20,000-$34,999 (p < 0.001). Study surveys measuring changes in awareness and attitudes toward PD research had mixed results. In Fox Insight, 181 participants were passively recruited with a shift toward more diverse participant demographics. CONCLUSION Research participation demographics reflective of the general population are critical to PD investigation and treatment. The FIRE-UP PD Study showed the effectiveness of localized community engagement strategies in increasing URG recruitment to PD research. Therefore, further PD research employing community-based methods to improve diverse participant recruitment is needed.
Collapse
Affiliation(s)
- Juliana M Ison
- University of California, Gevirtz Graduate School of Education, Isla Vista, Santa Barbara, CA 93106, USA
| | - Jonathan D Jackson
- Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA
| | - Helen Hemley
- Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA
| | - Allison Willis
- Perelman School of Medicine at the University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA 19104, USA
| | - Bernadette Siddiqi
- The Michael J. Fox Foundation, 111 W. 33rd St, New York City, NY 10120, USA
| | - Eric A Macklin
- Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA
| | - Christine Ulysse
- Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA
| | - Michael S Fitts
- University of Alabama at Birmingham (UAB Libraries), 1700 University Blvd, Birmingham, AL 35233, USA
| | - Tiffany T-H Pham
- Johns Hopkins School of Medicine, 733 N Broadway, Baltimore, MD 21205, USA
| | - Mitra Afshari
- Rush University Medical Center, 1620 W Harrison St, Chicago, IL 60612, USA
| | - Pinky Agarwal
- Evergreen Health Care, 12040 NE 128th St, Kirkland, WA 98034, USA
| | - Michael Aminoff
- University of California San Francisco, 400 Parnassus Ave, San Francisco, CA 94143, USA
| | - Stephanie Bissonnette
- Virginia Commonwealth University School of Medicine, 1201 E Marshall St #4-100, Richmond, VA 23298, USA
| | - Michelle Fullard
- University of Colorado Denver, 1201 Larimer St, Denver, CO 80204, USA
| | - Tarannum S Khan
- Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL 33331, USA
| | | | - Catherine Wielinski
- Park Nicollet Struthers Parkinson's Center, 6701 Country Club Dr, Minneapolis, MN 55427, USA
| | - Angie V Sanchez
- Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA; University of Louisiana at Lafayette, 104 E University Ave, Lafayette, LA 70504, USA.
| |
Collapse
|
32
|
Nix EP, Davis AG, Brown KD, Panoncillo SG, Thompson NJ, Overton AB, Dedmon MM, Dillon MT. Demographic Representation in Clinical Research Relative to a Cochlear Implant Patient Population. Laryngoscope 2024; 134:4101-4110. [PMID: 38656740 DOI: 10.1002/lary.31467] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/26/2024] [Revised: 04/04/2024] [Accepted: 04/08/2024] [Indexed: 04/26/2024]
Abstract
OBJECTIVES Research samples that are representative of patient populations are needed to ensure the generalizability of study findings. The primary aim was to assess the efficacy of a study design and recruitment strategy in obtaining a participant sample that was representative of the broader cochlear implant (CI) patient population at the CI center. A secondary aim was to review whether the CI recipient population was representative of the state population. METHODS Demographic variables were compared for a research participant sample (n = 79) and the CI patient population (n = 338). The participant sample was recruited from the CI patient population. The study design included visits that were at the same location and frequency as the recommended clinical follow-up intervals. The demographics for the combined group (participant sample and patient population) were then compared to the reported demographics for the population in North Carolina. RESULTS There were no significant differences between the participant sample and patient population for biological sex, age at implantation, racial distribution, socioeconomic position, degree of urbanization, or drive time to the CI center (p ≥ 0.086). The combined CI recipient population was significantly different from the North Carolina population for the distributions of race, ethnicity, and degree of urbanization (p < 0.001). CONCLUSION The study design and recruitment strategy allowed for recruitment of a participant sample that was representative of the CI patient population. Disparities in access to cochlear implantation persist, as supported by the significant differences in the combined CI recipient population and the population for our state. LEVEL OF EVIDENCE 3 Laryngoscope, 134:4101-4110, 2024.
Collapse
Affiliation(s)
- Evan P Nix
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A
| | - Amanda G Davis
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A
| | - Kevin D Brown
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A
| | - Stephanie G Panoncillo
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A
| | - Nicholas J Thompson
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A
| | - Andrea B Overton
- Department of Audiology, UNC Health, Chapel Hill, North Carolina, U.S.A
| | - Matthew M Dedmon
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A
| | - Margaret T Dillon
- Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A
| |
Collapse
|
33
|
Sinha A, Barwell L, Jeffery H, Peterson Z, Shifa B, Attia M, Badawy K, Purushotham A. Inclusivity of patients in early phase breast cancer clinical trials. J Cancer Policy 2024; 41:100494. [PMID: 39038736 DOI: 10.1016/j.jcpo.2024.100494] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2024] [Revised: 05/14/2024] [Accepted: 07/03/2024] [Indexed: 07/24/2024]
Abstract
INTRODUCTION Studies have shown that certain groups of patients are underrepresented in clinical trials including non-Caucasian ethnicity, poor fluency in English, low socioeconomic status, older age, neurodivergence, and large Body Mass Index (BMI). There is a need to ensure adequate representation of these groups so that the results of any trial accurately reflect the population. The aim of this study was to review the pathway of patients recruited into two early phase breast cancer clinical and determine the inclusivity of patients from the aforementioned sub-groups. METHODS The Breast Cancer Research Database was reviewed, and the characteristics of all patients who were screened for eligibility in two early phase clinical trials was examined. The English Indices of Deprivation was used to populate the Index of Multiple Deprivation (IMD) for each patient using their postcode. RESULTS In total, 392 patients were eligible to participate, between September 2020 to May 2023. Of these, 144 (36.7 %) were recruited to these two trials. In all, 100 % of patients eligible for these trials were approached and screened for participation. Eligible patients had a mean age of 53.5 years. Recruited patients were younger on average than those not recruited (49.1 years vs 56.0 years, p<0.0001). Only one recruited patient required an interpreter, compared with 24 (9.7 %%) of those who were not recruited (p<0.001). There was no difference in the IMD (p=0.38), BMI (p=0.34) and neurodiversity (p=0.10) between patients recruited into clinical trials and those who were not. CONCLUSION Older age and poor fluency in the English language remain barriers to participation in early-phase clinical trials despite implementing a clear pathway to trial recruitment. There is a pressing need to address these barriers by raising awareness, improve appropriate training and providing comprehensive trial information to patients in the language of their choice.
Collapse
Affiliation(s)
- A Sinha
- King's College London, London, United Kingdom; Guy's and St Thomas' NHS Foundation Trust, United Kingdom
| | - L Barwell
- King's College London, London, United Kingdom
| | - H Jeffery
- King's College London, London, United Kingdom; Guy's and St Thomas' NHS Foundation Trust, United Kingdom
| | - Z Peterson
- King's College London, London, United Kingdom; Guy's and St Thomas' NHS Foundation Trust, United Kingdom
| | - B Shifa
- King's College London, London, United Kingdom; Guy's and St Thomas' NHS Foundation Trust, United Kingdom
| | - M Attia
- Guy's and St Thomas' NHS Foundation Trust, United Kingdom; Department of General Surgery, Faculty of Medicine, Cairo University, Cairo, Egypt
| | - K Badawy
- King's College London, London, United Kingdom
| | - A Purushotham
- King's College London, London, United Kingdom; Guy's and St Thomas' NHS Foundation Trust, United Kingdom.
| |
Collapse
|
34
|
Podany EL, Bulsara S, Sanchez K, Otte K, Ellis MJ, Kinik M. Breast cancer clinical trial participation among diverse patients at a comprehensive cancer center. NPJ Breast Cancer 2024; 10:70. [PMID: 39097576 PMCID: PMC11297908 DOI: 10.1038/s41523-024-00672-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/01/2023] [Accepted: 07/10/2024] [Indexed: 08/05/2024] Open
Abstract
This study was designed to determine the enrollment patterns in breast cancer clinical trials (CCTs) of patients with diverse backgrounds in an equal access setting and to evaluate the factors contributing to low rates of clinical trial accrual in patients of low socioeconomic status (SES). We performed a retrospective review of a prospectively maintained database of new patients seen at the Dan L. Duncan Comprehensive Cancer Center dating from 5/2015 to 9/2021, which included 3043 patients screened for breast CCTs. We compared the rate of CCT availability, eligibility, and enrollment between two patient populations: Smith Clinic, where most patients are of low SES and uninsured, and Baylor St. Luke's Medical Center (BSLMC) with mostly predominantly insured, higher income patients. We performed logistic regression to evaluate whether differences in age, clinic, race, trial type, and primary language may be underlying the differences in CCT enrollment. More patients were eligible for CCTs at Smith Clinic (53.7% vs 44.7%, p < 0.001). However, Smith Clinic patients were more likely to decline CCT enrollment compared to BSLMC (61.3% declined vs 39.4%, p < 0.001). On multivariate analysis, Black patients had a significantly higher rate of CCT refusal overall (OR = 0.26, 95% CI 0.12-0.56, p < 0.001) and BSLMC only (OR = 0.20, 95% CI 0.060-0.60, p = 0.006). Our data shows that it is likely an oversimplification to assume that equal access will lead to the elimination of CCT disparities. Efforts to diversify CCTs must include consideration of structural and institutional inequities as well as social needs.
Collapse
Affiliation(s)
- Emily L Podany
- Baylor College of Medicine, Lester and Sue Smith Breast Center, Houston, TX, USA.
- Washington University in St. Louis, St. Louis, MO, USA.
| | - Shaun Bulsara
- Baylor College of Medicine, Lester and Sue Smith Breast Center, Houston, TX, USA
| | - Katherine Sanchez
- Baylor College of Medicine, Lester and Sue Smith Breast Center, Houston, TX, USA
| | - Kristen Otte
- Baylor College of Medicine, Lester and Sue Smith Breast Center, Houston, TX, USA
| | - Matthew J Ellis
- Baylor College of Medicine, Lester and Sue Smith Breast Center, Houston, TX, USA
- The Institute for Proteogenomic Discovery, Houston, TX, USA
| | - Maryam Kinik
- Baylor College of Medicine, Lester and Sue Smith Breast Center, Houston, TX, USA
| |
Collapse
|
35
|
Kibe LW, Bosah A, Schrode KM, Kuo Y, Shaheen M, Adinkra E, Sanchez H, Bazargan M. Assessing Food Access, Exercise, and Dietary History among Older African American Parishioners During the COVID-19 Pandemic (C-FED Study): Design, Opportunities, Challenges, and Lessons Learned. J Racial Ethn Health Disparities 2024; 11:1857-1868. [PMID: 37336866 PMCID: PMC11110797 DOI: 10.1007/s40615-023-01657-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/04/2023] [Revised: 05/20/2023] [Accepted: 05/24/2023] [Indexed: 06/21/2023]
Abstract
OBJECTIVES Unhealthy diets and inadequate exercise are associated with chronic health conditions and excess mortality. Older African Americans do not meet dietary and exercise guidelines, and this may have worsened during the COVID-19 pandemic due to individual and environmental factors, including food insecurity. Studies evaluating these dynamics are essential for developing interventions. This narrative details a study protocol and data collection experiences during the pandemic. METHODS Participants > 55 years African American old completed detailed food frequency, exercise, and food access questionnaires between October 2020 and July 2021. Observations of the study administrators (authors of this manuscript) for the duration of the study are presented. Details on the study design and reflections on the opportunities, challenges, and lessons learned are summarized. Future manuscripts will report data analysis of study findings. RESULTS A total of 123 older African American adults participated in the study, and 118 (70% female) completed all three questionnaires. More than 50% of the participants had at least two primary chronic conditions. About 85% were fully vaccinated against COVID-19. Applying community-based participatory approaches, leveraging partnerships, and exercising flexibility approaches were pivotal to successfully implementing the study protocol. CONCLUSIONS Despite challenges related to the COVID-19 pandemic, detailed data on older African American adults' diet and exercise habits were obtained. Our study design and experiences will benefit future researchers. More importantly, results from our study will inform interventions and policies aimed at minimizing consequences associated with poor diet and exercise habits during the pandemic among this vulnerable population.
Collapse
Affiliation(s)
- Lucy W Kibe
- Physician Assistant Program, Charles R. Drew University of Medicine and Science, 1731 E. 120Th St., Los Angeles, CA, 90059, USA.
| | - Adaobi Bosah
- Physician Assistant Program, Charles R. Drew University of Medicine and Science, 1731 E. 120Th St., Los Angeles, CA, 90059, USA
| | - Katrina M Schrode
- Department of Psychiatry, Charles R. Drew University of Medicine and Science, Los Angeles, CA, 90059, USA
| | - Yufu Kuo
- Physician Assistant Program, Charles R. Drew University of Medicine and Science, 1731 E. 120Th St., Los Angeles, CA, 90059, USA
| | - Magda Shaheen
- Department of Internal Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, CA, 90059, USA
| | - Edward Adinkra
- Department of Family Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, CA, 90059, USA
| | - Humberto Sanchez
- Office of Research, Charles R. Drew University of Medicine and Science, Los Angeles, CA, 90059, USA
| | - Mohsen Bazargan
- Physician Assistant Program, Charles R. Drew University of Medicine and Science, 1731 E. 120Th St., Los Angeles, CA, 90059, USA
- Department of Family Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, CA, 90059, USA
- Department of Family Medicine, University of California Los Angeles (UCLA), Los Angeles, CA, 90059, USA
| |
Collapse
|
36
|
Churchill V, Schoenberger YM, Carter VL, Chevrin JY, Dean-Colomb W, Matthews R, Rivers D, Sodeke SO, Ezer J, Rivers BM. Addressing Barriers and Facilitators to African Americans' and Hispanics' Participation in Clinical and Genomic Research Through a Bioethical Sensitive Video. JOURNAL OF CANCER EDUCATION : THE OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER EDUCATION 2024; 39:464-470. [PMID: 38693423 PMCID: PMC11219413 DOI: 10.1007/s13187-024-02433-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 03/26/2024] [Indexed: 05/03/2024]
Abstract
Research advances on effective methods to prevent, diagnose, and treat cancer continue to emerge through clinical and genomic research. Most clinical trial and genomic research participants identify as White which limits the generalizability of research findings to non-White populations. With the development and access to technology, digital delivery of salient and tailored health education may provide innovative pathways to increase representation of African Americans (AA) and Hispanics in research. This project focused on the creation of a bioethical sensitive education video aimed at increasing participation in clinical trials and genomic research by bringing together experts from the community, healthcare, biomedical research, and public health. The goal was to utilize existing educational resources to create a tailored message to address AA/Hispanics' beliefs, values, and bioethical concerns related to participation in clinical and genomic research. Models of behavior change and communication theories were leveraged to frame key components of the message, which then informed the framework for the animated video. Development of the video consisted of six iterative phases: 1) writing sessions; 2) storyboarding; 3) animating; 4) screening/revisions; 5) acceptability testing; 6) finalization. The final animated video is approximately 5 min in length and covers several topics including the goal of clinical research, disparities in research participation, bioethical concerns, and genomic research regulations. Increasing AA and Hispanic participation in clinical and genomic research is imperative to achieving health equity. Tailored messages via short videos may assist in addressing the barriers and facilitators towards research participation and increase intentions to enroll in trials.
Collapse
Affiliation(s)
- Victoria Churchill
- Cancer Health Equity Institute, Morehouse School of Medicine, 720 Westview Dr SW, Atlanta, GA, 30310, USA.
| | - Yu-Mei Schoenberger
- O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, 1824 6th Ave S, Birmingham, AL, 35233, USA
| | - Vivian L Carter
- Center for Biomedical Research, Tuskegee University, 1200 W Montgomery Rd, Tuskegee, AL, 36088, USA
| | - Jamirah Y Chevrin
- Cancer Health Equity Institute, Morehouse School of Medicine, 720 Westview Dr SW, Atlanta, GA, 30310, USA
| | - Windy Dean-Colomb
- Center for Biomedical Research, Tuskegee University, 1200 W Montgomery Rd, Tuskegee, AL, 36088, USA
- Piedmont Cancer Institute, 775 Poplar Rd, Suite 310 Newnan, Newnan, GA, 30265, USA
| | - Roland Matthews
- Cancer Health Equity Institute, Morehouse School of Medicine, 720 Westview Dr SW, Atlanta, GA, 30310, USA
| | - Desiree Rivers
- Cancer Health Equity Institute, Morehouse School of Medicine, 720 Westview Dr SW, Atlanta, GA, 30310, USA
| | - Stephen O Sodeke
- Center for Biomedical Research, Tuskegee University, 1200 W Montgomery Rd, Tuskegee, AL, 36088, USA
| | - Jonathan Ezer
- Kindea Labs, 70 Little W St #31E, New York, NY, 10004, USA
| | - Brian M Rivers
- Cancer Health Equity Institute, Morehouse School of Medicine, 720 Westview Dr SW, Atlanta, GA, 30310, USA
| |
Collapse
|
37
|
Perez GK, Rabin JT, Tandon M, Strauss NM, Irwin K, Philpotts L, Ostroff J, Park ER. Do Tobacco Treatment Trials Address Disparities in Smoking Outcomes Among Black and Hispanic Cancer Patients? A Systematic Review of Smoking Cessation Interventions for Black and Hispanic Patients Diagnosed with Cancer. J Racial Ethn Health Disparities 2024; 11:2390-2406. [PMID: 37468742 PMCID: PMC11236890 DOI: 10.1007/s40615-023-01705-3] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2022] [Revised: 05/30/2023] [Accepted: 06/27/2023] [Indexed: 07/21/2023]
Abstract
OBJECTIVE To characterize the representation of Black and Hispanic cancer patients in tobacco treatment trials, and to offer recommendations for future research. METHODS We conducted two systematic searches of the literature (2018, 2021) using 5 databases (MEDLINE via EBSCO, Pubmed, PsycInfo, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica Database (EMBASE)) to examine the prevalence of tobacco trials that included Black or Hispanic cancer patients. Two coders independently screened all articles at title, abstract, and full-text to identify eligible trials. Information about the proportion of Black and Hispanic patients included, trial design features, and whether the authors analyzed outcomes for Black and Hispanic patients were documented. RESULTS Of 4682 identified studies, only 10 published trials included and reported on the rates of Black or Hispanic cancer patients enrolled in their tobacco trial. The proportion of enrolled Black cancer patients ranged from 2 to 55.6%. Only our studies documented enrollment rates for Hispanics, and rates were less than 6%. None of the studies offered strategies to promote or the accrual of Black or Hispanic patients. DISCUSSION There remains a large gap in the literature regarding the reach and efficacy of tobacco treatment for Black and Hispanic cancer patients. Black and Hispanic cancer patients remain largely under-represented in tobacco cessation trials, limiting the applicability of existing, evidence-based treatments. To optimize intervention generalizability, future studies should emphasize the targeted recruitment and engagement of these patients in tobacco trials.
Collapse
Affiliation(s)
- Giselle K Perez
- Harvard Medical School/Massachusetts General Hospital, Boston, MA, USA.
- Health Promotion and Resilience Intervention Research Program, 100 Cambridge Street, 16th floor, Boston, MA, 02114, USA.
| | - Julia T Rabin
- Department of Psychology, University of Cincinnati, Cincinnati, OH, USA
| | | | | | - Kelly Irwin
- Harvard Medical School/Massachusetts General Hospital, Boston, MA, USA
- Health Promotion and Resilience Intervention Research Program, 100 Cambridge Street, 16th floor, Boston, MA, 02114, USA
| | - Lisa Philpotts
- Harvard Medical School/Massachusetts General Hospital, Boston, MA, USA
| | - Jamie Ostroff
- Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Elyse R Park
- Harvard Medical School/Massachusetts General Hospital, Boston, MA, USA
- Health Promotion and Resilience Intervention Research Program, 100 Cambridge Street, 16th floor, Boston, MA, 02114, USA
| |
Collapse
|
38
|
Sanchez P, Van Dyke AL, Petkov VI, Yuan Y, Bonds S, Valenzuela C, Tuan AW, Moravec R, Altekruse SF, Singhi AD, Serdy KM, Wu Y, Cress RD, Doherty JA, Mueller L, Hernandez BY, Lynch CF, Tucker TC, Wu XC, Matrisian L, Penberthy L. NCI SEER-Linked Virtual Tissue Repository Pilot. J Natl Cancer Inst Monogr 2024; 2024:180-190. [PMID: 39102878 DOI: 10.1093/jncimonographs/lgae034] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/04/2024] [Revised: 05/03/2024] [Accepted: 06/03/2024] [Indexed: 08/07/2024] Open
Abstract
BACKGROUND The Surveillance, Epidemiology, and End Results (SEER) Program with the National Cancer Institute tested whether population-based cancer registries can serve as honest brokers to acquire tissue and data in the SEER-Linked Virtual Tissue Repository (VTR) Pilot. METHODS We collected formalin-fixed, paraffin-embedded tissue and clinical data from patients with pancreatic ductal adenocarcinoma (PDAC) and breast cancer (BC) for two studies comparing cancer cases with highly unusual survival (≥5 years for PDAC and ≤30 months for BC) to pair-matched controls with usual survival (≤2 years for PDAC and ≥5 years for BC). Success was defined as the ability for registries to acquire tissue and data on cancer cases with highly unusual outcomes. RESULTS Of 98 PDAC and 103 BC matched cases eligible for tissue collection, sources of attrition for tissue collection were tissue being unavailable, control paired with failed case, second control that was not requested, tumor necrosis ≥20%, and low tumor cellularity. In total, tissue meeting the study criteria was obtained for 70 (71%) PDAC and 74 (72%) BC matched cases. For patients with tissue received, clinical data completeness ranged from 59% for CA-19-9 after treatment to >95% for margin status, whether radiation therapy and chemotherapy were administered, and comorbidities. CONCLUSIONS The VTR Pilot demonstrated the feasibility of using SEER cancer registries as honest brokers to provide tissue and clinical data for secondary use in research. Studies using this program should oversample by 45% to 50% to obtain sufficient sample size and targeted population representation and involve subspecialty matter expert pathologists for tissue selection.
Collapse
Affiliation(s)
- Pamela Sanchez
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA
| | - Alison L Van Dyke
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA
| | - Valentina I Petkov
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA
| | - Yao Yuan
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA
| | - Sarah Bonds
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA
| | - Connor Valenzuela
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA
| | - Alyssa W Tuan
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA
| | - Radim Moravec
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA
| | - Sean F Altekruse
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA
| | - Aatur D Singhi
- Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
| | - Kate M Serdy
- Department of Pathology, Allegheny Health Network, Pittsburgh, PA, USA
| | - Yun Wu
- Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA
| | - Rosemary D Cress
- Public Health Institute, Cancer Registry of Greater California, Sacramento, CA, USA
| | - Jennifer A Doherty
- The Utah Cancer Registry, Salt Lake City, UT, USA
- Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA
| | - Lloyd Mueller
- Connecticut Tumor Registry, Connecticut State Department of Public Health, Hartford, CT, USA
| | - Brenda Y Hernandez
- The Hawaii Tumor Registry, University of Hawaii Cancer Center, Honolulu, HI, USA
| | - Charles F Lynch
- The Iowa Cancer Registry, The University of Iowa, Iowa City, IA, USA
| | - Thomas C Tucker
- Kentucky Cancer Registry, Markey Cancer Center, University of Kentucky, Lexington, KY, USA
| | - Xiao-Cheng Wu
- The Louisiana Tumor Registry, Louisiana State University School of Public Health, New Orleans, LA, USA
| | - Lynn Matrisian
- Scientific and Medical Affairs, Pancreatic Cancer Action Network (PanCAN), Manhattan Beach, CA, USA
| | - Lynne Penberthy
- Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA
| |
Collapse
|
39
|
Collister D, Song C, Ruzycki SM. Fostering diversity in clinical trials: need for evidence and implementation to improve representation. BMJ MEDICINE 2024; 3:e000984. [PMID: 39175921 PMCID: PMC11340663 DOI: 10.1136/bmjmed-2024-000984] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 06/05/2024] [Accepted: 06/25/2024] [Indexed: 08/24/2024]
Affiliation(s)
- David Collister
- Department of Medicine, University of Alberta Faculty of Medicine and Dentistry, Edmonton, Alberta, Canada
| | - Claire Song
- University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
| | - Shannon M Ruzycki
- Department of Medicine, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
| |
Collapse
|
40
|
Barton KS, Porter KM, Mai T, Claw KG, Hiratsuka VY, Carroll SR, Burke W, Garrison NA. Genetic research within Indigenous communities: Engagement opportunities and pathways forward. Genet Med 2024; 26:101158. [PMID: 38699966 DOI: 10.1016/j.gim.2024.101158] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2023] [Revised: 04/24/2024] [Accepted: 04/25/2024] [Indexed: 05/05/2024] Open
Abstract
PURPOSE Against a historical backdrop of researchers who violated trust through lack of benefit sharing, transparency, and engagement, efforts are underway to develop better approaches for genetic and genomic research with Indigenous communities. To increase engagement, there is a need to understand factors that affect researcher and community collaborations. This study aimed to understand the barriers, challenges, and facilitators of Indigenous Peoples in the United States participating in genetic research. METHODS We conducted 42 semistructured interviews with Tribal leaders, clinicians, researchers, policy makers, and Tribal research review board members across the United States to explore perceived risks, benefits, barriers, and facilitators of genetic research participation. RESULTS Participants, identifying as Indigenous (88%) or non-Indigenous allies (12%), described their concerns, hesitancy, and fears about genetic research, as well as the roles of trust, transparency, and respect for culture in facilitating partnerships. Previous harms-such as sample and data misuse, stigmatization, or misrepresentation by researchers-revealed strategies for building trust to create more equitable and reciprocal research partnerships. CONCLUSION Participants in this study offered strategies for increasing genetic research engagement. The pathway forward should foster transparent research policies and practices to facilitate informed research that supports the needs and priorities of participants, communities, and researchers.
Collapse
Affiliation(s)
- Krysta S Barton
- Biostatistics Epidemiology and Analytics for Research (BEAR) Core, Seattle Children's Research Institute, Seattle, WA
| | - Kathryn M Porter
- Treuman Katz Center for Pediatric Bioethics and Palliative Care, Seattle Children's Research Institute, Seattle, WA
| | - Thyvu Mai
- Institute for Public Health Genetics, University of Washington School of Medicine, Seattle, WA
| | - Katrina G Claw
- Department of Biomedical Informatics, Colorado Center for Personalized Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO
| | - Vanessa Y Hiratsuka
- Center for Human Development, College of Health, University of Alaska Anchorage, Anchorage, AK; Southcentral Foundation, Anchorage, AK
| | - Stephanie Russo Carroll
- Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ; Native Nations Institute, Udall Center for Studies in Public Policy, University of Arizona, Tucson, AZ
| | - Wylie Burke
- Department of Bioethics and Humanities, University of Washington School of Medicine, Seattle, WA
| | - Nanibaa' A Garrison
- Institute for Society and Genetics, University of California, Los Angeles, Los Angeles, CA; Institute for Precision Health, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA; Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA.
| |
Collapse
|
41
|
Choradia N, Karzai F, Nipp R, Naqash AR, Gulley JL, Floudas CS. Increasing diversity in clinical trials: demographic trends at the National Cancer Institute, 2005-2020. J Natl Cancer Inst 2024; 116:1063-1071. [PMID: 38374401 PMCID: PMC11223850 DOI: 10.1093/jnci/djae018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/28/2023] [Revised: 12/14/2023] [Accepted: 01/18/2024] [Indexed: 02/21/2024] Open
Abstract
BACKGROUND We described participant demographics for National Cancer Institute (NCI) clinical trials at the clinical center (NCI-CC participants) of the National Institutes of Health to identify enrollment disparities. METHODS We analyzed NCI-CC data from 2005 to 2020, calculated enrollment fractions, compared with the US cancer population represented by the Surveillance, Epidemiology, and End Results cancer incidence data (2018) and the Cancer in North America database (2018), and compared further with clinical trial disparities data from the NCI Community Oncology Research Program and National Clinical Trials Network (2005-2019), and from ClinicalTrials.gov (2003-2016). RESULTS NCI-CC (38 531 participants) had higher enrollment fractions for older adults (8.5%), male (5.6%), non-Hispanic (5.1%), and Black or African American (5.3%) participants; lower women proportion across race and ethnicity; and fewer female sex-specific cancer (6.8%) than male sex-specific cancer (11.7%) participants. NCI-CC had lower median age than Surveillance, Epidemiology, and End Results (54.0 vs 65.4); more Black or African American participants (12.0% vs 11.1%); and fewer women (41.7% vs 49.5%), White (76.1% vs 80.5%), Asian or Pacific Islander (4.6% vs 6.0%), American Indian or Alaska Native (0.3% vs 0.5%), and Hispanic participants (7.1% vs 13%). NCI-CC had more Black or African American and Asian or Pacific Islander participants; fewer Hispanic participants than the NCI Community Oncology Research Program and National Clinical Trials Network; more Black or African American and Hispanic participants; fewer Asian or Pacific Islander participants than ClinicalTrials.gov data. Improvement was noted for NCI-CC (older adults, Black or African American, Asian or Pacific Islander, Hispanic participants). CONCLUSION We found lower representation of older adults, women, Asian or Pacific Islander, American Indian or Alaska Native, and Hispanic participants vs the US cancer population and higher representation of Black or African American vs US cancer population and oncology clinical trials. Multifaceted efforts are underway to reduce disparities in cancer clinical trials at the NCI-CC.
Collapse
Affiliation(s)
- Nirmal Choradia
- Medical Oncology Service, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
| | - Fatima Karzai
- Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
| | - Ryan Nipp
- Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA
| | - Abdul Rafeh Naqash
- Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA
| | - James L Gulley
- Center for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
| | - Charalampos S Floudas
- Center for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
| |
Collapse
|
42
|
Sledge D, Hoang BL. Racial/ethnic representation in opioid use disorder-related clinical trials. JOURNAL OF SUBSTANCE USE AND ADDICTION TREATMENT 2024; 161:209338. [PMID: 38537872 DOI: 10.1016/j.josat.2024.209338] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/18/2023] [Revised: 02/13/2024] [Accepted: 03/06/2024] [Indexed: 04/13/2024]
Abstract
BACKGROUND Little is known about representation in trials aimed at addressing Opioid Use Disorder. This is a crucial issue given high mortality rates overall and substantial differences in death rates across racial/ethnic groups. METHODS We analyzed data from clinical trials, data on Census population, data on new admissions to treatment facilities with a diagnosis of Opioid Use Disorder, and mortality data. RESULTS We found that Native American people (who face the highest opioid-related mortality burden in the United States) were under-represented in clinical trials. Black people (who face the second highest mortality rate) were enrolled at levels that exceeded those expected. Our results suggest the need for increased efforts to include Native Americans in OUD clinical trials and also that researchers should consider the possibility that high levels of enrollment among black Americans may represent an undue burden. We found ambiguous results for Asian American and Hispanic people. Our analysis also suggests that White people were represented at levels below those expected, although they were a majority of clinical trials participants. CONCLUSION Overall, these findings highlight the importance of equity in clinical trials and major gaps in terms of representation.
Collapse
Affiliation(s)
- Daniel Sledge
- Health Administration and Policy, Hudson College of Public Health, The University of Oklahoma Health Sciences, United States of America.
| | - Bai Linh Hoang
- Political Science, The University of Texas at Arlington, United States of America
| |
Collapse
|
43
|
Kissel HA, Lee GH, McFarland S, Berger D, Enneking E, Dunham J, Brumback T. Participant diversity in ACER: 2010-2022. ALCOHOL, CLINICAL & EXPERIMENTAL RESEARCH 2024; 48:1189-1204. [PMID: 38653579 DOI: 10.1111/acer.15324] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/14/2023] [Revised: 03/06/2024] [Accepted: 03/21/2024] [Indexed: 04/25/2024]
Abstract
BACKGROUND Increasing diversity has become a priority for all fields working with human subjects due to historic exclusions and misrepresentations of participants with minoritized identities. To create a more representative and generalizable science of alcohol use, the Research Society on Alcohol (RSA) and its official journal, Alcohol: Clinical and Experimental Research (ACER), have increasingly incorporated diversity and inclusion into their posted values and programming. METHODS We analyzed the content of articles published in ACER from 2010 through 2022 (6 years before and after the formation of RSA's Diversity Committee) to assess the reporting of participants' demographic information and whether there has been increased inclusion of diverse samples in alcohol research over time. Our team screened 3292 abstracts for data extraction; studies were included if they were primary analyses of data collected from human subjects (n = 1043). RESULTS Reporting of all demographic variables increased over time, with significant increases in reporting for race/ethnicity, sexual orientation, gender identity, socioeconomic status (SES), income, and educational attainment. Demographic variables were also increasingly used in analyses. However, representation of research outside the United States diminished significantly over time. CONCLUSIONS We provide recommended journal article reporting standards for ACER to continue the positive progress in reporting demographics in alcohol research and facilitate meta-analyses examining demographic modulation and the impact of social determinants of health.
Collapse
Affiliation(s)
- Heather A Kissel
- Department of Psychological Sciences, Northern Kentucky University, Highland Heights, Kentucky, USA
| | - Ga Hee Lee
- Department of Psychological Sciences, Northern Kentucky University, Highland Heights, Kentucky, USA
| | - Sara McFarland
- Department of Psychological Sciences, Northern Kentucky University, Highland Heights, Kentucky, USA
| | - Dexton Berger
- Department of Psychological Sciences, Northern Kentucky University, Highland Heights, Kentucky, USA
| | - Elizabeth Enneking
- Department of Psychological Sciences, Northern Kentucky University, Highland Heights, Kentucky, USA
| | - Jenna Dunham
- Department of Psychological Sciences, Northern Kentucky University, Highland Heights, Kentucky, USA
| | - Ty Brumback
- Department of Psychological Sciences, Northern Kentucky University, Highland Heights, Kentucky, USA
| |
Collapse
|
44
|
Morgan SE, Harrison TR, Wright KO, Malova E, Deal B, Jia X. Reducing Health Disparities Among African American and Black Caribbean Patients by Improving the Communication Practices of Clinical Research Coordinators. HEALTH COMMUNICATION 2024; 39:1298-1309. [PMID: 37165558 DOI: 10.1080/10410236.2023.2211740] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/12/2023]
Abstract
This manuscript focuses on the communication factors that affect the willingness of African Americans and Black Caribbean patients to participate in clinical trials and research studies. Low rates of research participation by members of communities of color have long been linked to health disparities. While there are many factors that contribute to low rates of accrual of African American and Black patients to clinical trials, a lack of attention to communication factors that enhance or inhibit the recruitment process is central to the problem. In this study, we describe results from the analysis of six focus groups (N = 31) consisting of African American (k = 3) and Black Caribbean (k = 3) participants. Our analyses focus on verbal and nonverbal communication behaviors and how they affect participants' willingness to participate in clinical trials. Specifically, when clinical research coordinators (CRCs) had a professional appearance, made the effort to explain a study in detail, made eye contact, took the time to listen and answer questions patiently, and gave the sense that the CRC was being truthful and transparent, patients felt respected and valued. Additionally, participants emphasized the importance of the process of developing and maintaining a trusting relationship between study participants and CRCs. The results of this study will be used to develop a clinical trial communication training program designed to enhance the communication skills of clinical research coordinators who discuss research participation with African American and Caribbean Black patients.
Collapse
Affiliation(s)
| | | | | | | | - Bonnie Deal
- School of Communication, University of Miami
| | | |
Collapse
|
45
|
Fairley R, Lillard JW, Berk A, Cornew S, Gaspero J, Gillespie J, Horne LL, Kidane S, Munro SB, Parsons M, Powers ER, Rizzo SE, Tishcler A, Wohl H, Weiss MC. Increasing Clinical Trial Participation of Black Women Diagnosed with Breast Cancer. J Racial Ethn Health Disparities 2024; 11:1701-1717. [PMID: 37314691 PMCID: PMC11101578 DOI: 10.1007/s40615-023-01644-z] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2023] [Revised: 05/12/2023] [Accepted: 05/15/2023] [Indexed: 06/15/2023]
Abstract
Despite racial disparities in breast cancer mortality, Black women remain underrepresented in clinical trials. In this mixed methods research, 48 Black women were engaged via focus group discussions and in-depth interviews to better understand the lived experience of women with breast cancer. The results of this qualitative study informed the development of a subsequent online survey to identify barriers, motivators, and other factors that influence decision-making by Black women diagnosed with breast cancer when considering clinical trial participation. Among the 257 Black survey participants, most (95%) were aware of clinical trials; of those, most viewed them as lifesaving (81%) and/or benefiting others (90%). Negative perceptions such as serious side effects (58%), not receiving real treatment (52%), or risk of potential harm (62%) were indicated. Barriers included financial expenses (49%), concerns that their condition could be made worse (29%), that they would receive a placebo (28%), or that treatment was unapproved (28%). Participants were more likely than their health care providers (HCPs) to initiate discussions of clinical trials (53% versus 33%), and 29% of participants indicated a need for more information about risks and benefits, even after having those conversations. The most trustworthy sources of information on clinical trials were HCPs (66%) and breast cancer support groups (64%). These results suggest that trusted communities are key for providing education on clinical trials. However, there is also a need for HCPs to proactively discuss clinical trials with patients to ensure that they are adequately informed about all aspects of participation.
Collapse
Affiliation(s)
- Ricki Fairley
- TOUCH, The Black Breast Cancer Alliance, Annapolis, MD, USA
| | - James W Lillard
- Department of Microbiology, Biochemistry, and Immunology, Morehouse School of Medicine, Atlanta, GA, USA
| | | | - Sophia Cornew
- Patient Network and Data, Invitae, San Francisco, CA, USA
| | | | | | - LaTrisha L Horne
- Department of Microbiology, Biochemistry, and Immunology, Morehouse School of Medicine, Atlanta, GA, USA
| | | | | | | | - Emily R Powers
- TOUCH, The Black Breast Cancer Alliance, Annapolis, MD, USA.
| | | | | | | | - Marisa C Weiss
- Breastcancer.org, Ardmore, PA, USA
- Lankenau Medical Center, Wynnewood, PA, USA
| |
Collapse
|
46
|
Karmali R, Machhi R, Epperla N, Shouse G, Romancik J, Moyo TK, Kenkre V, Ollila TA, Fitzgerald L, Hess B, David K, Roy I, Zurko J, Chowdhury SM, Annunzio K, Ferdman R, Bhansali RS, Harris EI, Liu J, Nizamuddin I, Ma S, Moreira J, Winter J, Pro B, Stephens DM, Danilov A, Shah NN, Cohen JB, Barta SK, Torka P, Gordon LI. Impact of race and social determinants of health on outcomes in patients with aggressive B-cell NHL treated with CAR-T therapy. Blood Adv 2024; 8:2592-2599. [PMID: 38531057 PMCID: PMC11145749 DOI: 10.1182/bloodadvances.2023011996] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/13/2023] [Revised: 02/05/2024] [Accepted: 02/26/2024] [Indexed: 03/28/2024] Open
Abstract
ABSTRACT Chimeric antigen receptor (CAR) T-cell (CAR-T) immunotherapy is an effective therapy for relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). However, data are limited on the impact of the convergence of race and social determinants of health on outcomes for patients treated with CAR-T therapy. We examined the impact of interactions between race and insurance type on health care use and outcomes in patients treated with CAR-T therapy for aggressive B-NHL. Adult patients with r/r B-NHL treated with CD19 CAR-Ts were identified between 2015 and 2021 across 13 US academic centers. Insurance type, demographic, and clinical data were collected and analyzed. In total, 466 adult patients were included in our analysis. Median follow-up after CAR-T therapy was 12.7 months. Median progression-free survival (mPFS) was longer for Caucasians (11.5 months) than for African Americans (3.5 months; hazard ratio [HR], 1.56 [1.03-2.4]; P = .04) or Asians (2.7 months; HR, 1.7 [1.02-2.67]; P = .04). Differences in median overall survival (mOS) were not significant. For Medicare (n = 206) vs Medicaid (n = 33) vs private insurance (n = 219) vs self-pay (n = 7): mPFS was 15.9 vs 4.2 vs 6.0 vs 0.9 months (P < .001), respectively; and mOS was 31.2 vs 12.8 vs 21.5 vs 3.2 months (P < .001), respectively. Our multicenter retrospective analysis showed that race and insurance status can affect outcomes for patients treated with CAR-T therapy.
Collapse
Affiliation(s)
- Reem Karmali
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL
| | - Rushad Machhi
- Northwestern University, Feinberg School of Medicine, Chicago, IL
| | - Narendranath Epperla
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH
| | | | | | | | - Vaishalee Kenkre
- Carbone Cancer Center, University of Wisconsin–Madison, Madison, WI
| | | | | | - Brian Hess
- Hollings Cancer Center, Medical University of South Carolina, Charleston, SC
| | - Kevin David
- Rutgers Cancer Institute of New Jersey, Rutgers University, New Brunswick, NJ
| | - Ishan Roy
- Roswell Park Comprehensive Cancer Center, Buffalo, NY
| | - Joanna Zurko
- Carbone Cancer Center, University of Wisconsin–Madison, Madison, WI
| | - Sayan Mullick Chowdhury
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH
| | - Kaitlin Annunzio
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH
| | | | - Rahul S. Bhansali
- Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA
| | - Elyse I. Harris
- Carbone Cancer Center, University of Wisconsin–Madison, Madison, WI
| | - Jieqi Liu
- Rutgers Cancer Institute of New Jersey, Rutgers University, New Brunswick, NJ
| | - Imran Nizamuddin
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL
| | - Shuo Ma
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL
| | - Jonathan Moreira
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL
| | - Jane Winter
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL
| | - Barbara Pro
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL
| | | | | | - Nirav N. Shah
- MCW Cancer Center, Medical College of Wisconsin, Milwaukee, WI
| | | | - Stefan K. Barta
- Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA
| | - Pallawi Torka
- Roswell Park Comprehensive Cancer Center, Buffalo, NY
| | - Leo I. Gordon
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL
| |
Collapse
|
47
|
Rieder SM, Burgess E, Rutledge T, Sussman A, Boyce T, Pankratz VS, Kano M. Critical decisions: A mixed-methods study of decision-making among diverse gynecologic cancer patients considering therapeutic clinical trial enrollment. Gynecol Oncol 2024; 184:103-110. [PMID: 38301308 DOI: 10.1016/j.ygyno.2024.01.031] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2023] [Revised: 01/16/2024] [Accepted: 01/20/2024] [Indexed: 02/03/2024]
Abstract
OBJECTIVE Participation in therapeutic clinical trials does not reflect the diversity of gynecologic cancer patients, limiting access to novel therapeutics and generalizability of results. Reasons for inequities in participation among historically underrepresented populations remain undertheorized, as studies have shown equal willingness to participate among groups. We sought to apply a precarity framework to conceptualize the factors that impact patients' desire to enroll, to improve equity in gynecologic oncology clinical trial participation. METHODS Gynecologic cancer patients at a single tertiary care facility in the Southwestern United States who discussed participation in therapeutic clinical trial with their oncology provider from 2020 to 2021 were identified. Enrolled participants completed surveys and qualitative interviews regarding treatment experiences and decision-making. Oncology providers completed parallel surveys at the time of their patient's enrollment. Descriptive statistics and thematic coding were used to analyze data. RESULTS 30 patients were enrolled and participated in surveys and interviews. No differences were found in quantitative data assessing shared decision-making and patient-centered communication between those who enrolled and those who did not. Qualitative data demonstrated that patients who declined trial enrollment expressed concerns regarding uncertainty and loss of control, independence in decision-making, and significant resource challenges and financial toxicity of cancer treatment. CONCLUSIONS We identified a constellation of factors that contribute to desire to enroll in clinical trials, that we describe using the framework of precarity. Through identification of precarious patients and mitigation of burdens, we anticipate improved enrollment and retention in therapeutic clinical trials among diverse gynecologic oncology patients.
Collapse
Affiliation(s)
- Stephanie Margrit Rieder
- University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA; Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM, USA.
| | - Ellen Burgess
- University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA
| | - Teresa Rutledge
- University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA; Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM, USA
| | - Andrew Sussman
- University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA; Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA
| | - Tawny Boyce
- University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA
| | | | - Miria Kano
- University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA; Department of Internal Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA
| |
Collapse
|
48
|
Steventon L, Nicum S, Man K, Chaichana U, Wei L, Chambers P. A systematic review of ethnic minority participation in randomised controlled trials of systemic therapies for gynecological cancers. Gynecol Oncol 2024; 184:178-189. [PMID: 38330832 DOI: 10.1016/j.ygyno.2024.01.052] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2023] [Revised: 01/10/2024] [Accepted: 01/30/2024] [Indexed: 02/10/2024]
Abstract
OBJECTIVE Randomised controlled trials (RCTs) must include ethnic minority patients to produce generalisable findings and ensure health equity as cancer incidence rises globally. This systematic review examines participation of ethnic minorities in RCTs of licensed systemic anti-cancer therapies (SACT) for gynecological cancers, defining the research population and distribution of research sites to identify disparities in participation on the global scale. METHODS A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. Phase II and III RCTs of licensed therapies for gynecological cancers published 01/11/2012-01/11/2022 that reported patient race/ethnicity were included. Extracted data included race/ethnicity and research site location. RCT populations were aggregated and participation of groups compared. Global distribution of research sites was described. RESULTS 26 RCTs met inclusion criteria of 351 publications included in full-text screening, representing 17,041 patients. 79.8% were "Caucasian", 9.1% "East Asian", 3.7% "Black/African American" and 6.1% "Other, Unknown, Not Reported". "Caucasian" patients participated at higher rates than all other groups. Of 5,478 research sites, 80.1% were located in North America, 13.0% in Europe, 3.4% in East Asia, 1.3% in the Middle East, 1.3% in South America and 0.8% in Australasia. CONCLUSIONS Ethnic minorities formed smaller proportions of RCT cohorts compared to the general population. The majority of sites were located in North America and Europe, with few in other regions, limiting enrollment of South Asian, South-East Asian and African patients in particular. Efforts to recruit more ethnic minority patients should be made in North America and Europe. More sites in underserved regions would promote equitable access to RCTs and ensure findings are generalisable to diverse groups. This review assessed the global population enrolled in contemporary RCTs for novel therapies now routinely given for gynecological cancers, adding novel understanding of the global distribution of research sites.
Collapse
Affiliation(s)
- Luke Steventon
- UCL School of Pharmacy, Mezzanine Floor, BMA House, Tavistock Square, London WC1H 9EU, United Kingdom; University College London Hospitals NHS Foundation Trust, Medical Oncology Department, 250 Euston Road, London NW1 2PG, United Kingdom
| | - Shibani Nicum
- University College London Hospitals NHS Foundation Trust, Medical Oncology Department, 250 Euston Road, London NW1 2PG, United Kingdom; UCL Cancer Institute, Department of Oncology, 72 Huntley Street, London WC1 6DD, United Kingdom
| | - Kenneth Man
- UCL School of Pharmacy, Mezzanine Floor, BMA House, Tavistock Square, London WC1H 9EU, United Kingdom
| | - Ubonphan Chaichana
- UCL School of Pharmacy, Mezzanine Floor, BMA House, Tavistock Square, London WC1H 9EU, United Kingdom
| | - Li Wei
- UCL School of Pharmacy, Mezzanine Floor, BMA House, Tavistock Square, London WC1H 9EU, United Kingdom
| | - Pinkie Chambers
- UCL School of Pharmacy, Mezzanine Floor, BMA House, Tavistock Square, London WC1H 9EU, United Kingdom; University College London Hospitals NHS Foundation Trust, Medical Oncology Department, 250 Euston Road, London NW1 2PG, United Kingdom.
| |
Collapse
|
49
|
Bania A, Adamou A, Saloustros E. Racial and Ethnic Disparities in European Breast Cancer Clinical Trials. Cancers (Basel) 2024; 16:1726. [PMID: 38730678 PMCID: PMC11082959 DOI: 10.3390/cancers16091726] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2024] [Revised: 04/26/2024] [Accepted: 04/27/2024] [Indexed: 05/13/2024] Open
Abstract
Breast cancer is the most prevalent female cancer worldwide with known correlations between the race and tumor characteristics of the patients and prognosis. International and US-based studies, however, have reported a disproportionate representation of Black and Hispanic patients in clinical trials. This is the first study assessing race and ethnicity reporting trends and inclusion in European breast cancer trials. The PubMed and ClinicalTrials.gov databases were systematically searched for trials on breast cancer treatment conducted exclusively in Europe between 2010 and 2022. Of the 97 identified trials, race was reported in 10.31%. Multinational participation, but not the study size or trial phase, was significantly associated with higher race reporting trends. These 10 trials featured a White-predominant population, with 1.08% Asian and 0.88% Black patients included. The acquisition of the race and ethnicity data of patients in European trials is lower compared to the U.S. or worldwide studies and does not permit extensive analysis of minority participation. In a limited analysis, the low rates of minority participation are concerning, based on population-based data on minorities in select European countries. These observations should encourage race reporting practices in European breast cancer trials and adequate minority participation to support the generalizability of the results of the studies and promote healthcare equity.
Collapse
Affiliation(s)
- Angelina Bania
- Faculty of Medicine, School of Health Sciences, University of Patras, 26504 Patras, Greece;
| | - Antonis Adamou
- Institute of Diagnostic and Interventional Neuroradiology, Hannover Medical School, 30625 Hannover, Germany;
| | - Emmanouil Saloustros
- Division of Oncology, Faculty of Medicine, School of Health Sciences, University of Thessaly, 41110 Larissa, Greece
| |
Collapse
|
50
|
Wippold GM, Crichlow ZR, Garcia KA, Domlyn A, Sanchez S, Frank L, Mote T, Frary SG, Woods T. Assessing organizational readiness for the Clean Cuts and Sharp Minds Collective: a barbershop health promotion network. Implement Sci Commun 2024; 5:42. [PMID: 38627824 PMCID: PMC11022399 DOI: 10.1186/s43058-024-00584-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2024] [Accepted: 04/10/2024] [Indexed: 04/19/2024] Open
Abstract
BACKGROUND Black men have among the lowest life expectancy in the United States. Alarmingly, these men are underrepresented in health promotion efforts. There are well-documented barriers to recruiting and retaining Black men in health promotion efforts, such as exclusionary research practices - many researchers may be hesitant to reach Black men in culturally unique spaces, such as barbershops. Despite these practices, qualitative research among Black men unanimously find that Black men are interested in health promotion efforts. The Clean Cuts and Sharp Minds Collective (CCSMC) was designed to bridge this gap. The objectives of the CCSMC are to train barbers to be lay advocates for their clients, train barbers to be research partners, and serve as a nexus between barbers interested in health promotion at their shops and researchers interested in implementing such efforts. The present study sought to assess the organizational readiness of barbershops in South Carolina (SC) to participate in the CCSMC. METHODS Barbers in SC were invited to complete a modified version of the Readiness Thinking Tool to assess organizational readiness to participate in the CCSMC. RESULTS Thirty-six (36; mean age = 41.12; 94.4% identified as Black; 91.7% identified as male) barbers completed the organizational readiness assessment. Results indicated that there was a high level of motivation, innovation-specific capacity, and general capacity within barbershops to participate in the CCSMC. Additionally, many barbers indicated that there would be widespread support to join the CCSMC. CONCLUSIONS The results from the present study highlight exciting opportunities and future directions for barbershop-academic partnerships. Such partnerships have the potential to promote health equity among, and in partnership with, Black men.
Collapse
Affiliation(s)
- Guillermo M Wippold
- Department of Psychology, University of South Carolina, 1512 Pendleton Avenue, Barnwell College, Mailbox 38, Columbia, SC, 29208, USA.
| | - Zion R Crichlow
- Department of Psychology, University of South Carolina, 1512 Pendleton Avenue, Barnwell College, Mailbox 38, Columbia, SC, 29208, USA
| | - Kaylyn A Garcia
- Department of Psychology, University of South Carolina, 1512 Pendleton Avenue, Barnwell College, Mailbox 38, Columbia, SC, 29208, USA
| | - Ariel Domlyn
- Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA
| | - Shane Sanchez
- Department of Psychology, University of South Carolina, 1512 Pendleton Avenue, Barnwell College, Mailbox 38, Columbia, SC, 29208, USA
| | - Lucina Frank
- Department of Psychology, University of South Carolina, 1512 Pendleton Avenue, Barnwell College, Mailbox 38, Columbia, SC, 29208, USA
| | - Thrisha Mote
- Department of Psychology, University of South Carolina, 1512 Pendleton Avenue, Barnwell College, Mailbox 38, Columbia, SC, 29208, USA
| | - Sarah Grace Frary
- Department of Psychology, University of South Carolina, 1512 Pendleton Avenue, Barnwell College, Mailbox 38, Columbia, SC, 29208, USA
| | - Terry Woods
- Main Attraction Barbershop, Sumter, SC, USA
- Healthy Mind, Body, and Family Foundation, Sumter, SC, USA
| |
Collapse
|