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Russo L, Siena LM, Farina S, Pastorino R, Boccia S, Ioannidis JPA. High-impact trials with genetic and -omics information focus on cancer mutations, are industry-funded, and less transparent. J Clin Epidemiol 2025; 180:111676. [PMID: 39826627 DOI: 10.1016/j.jclinepi.2025.111676] [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: 10/29/2024] [Revised: 12/20/2024] [Accepted: 01/07/2025] [Indexed: 01/22/2025]
Abstract
OBJECTIVES To assess how genetics and -omics information is used in the most cited recent clinical trials and to evaluate industry involvement and transparency patterns. STUDY DESIGN AND SETTING This is a meta-research evaluation using a previously constructed database of the 600 most cited clinical trials published from 2019 to 2022. Trials that utilized genetic or -omics characterization of participants in the trial design, analysis, and results were considered eligible. RESULTS 132 (22%) trials used genetic or -omics information, predominantly for detection of cancer mutations (n = 101). Utilization included eligibility criteria (n = 59), subgroup analysis (n = 82), and stratification factor in randomization (n = 14). Authors addressed the relevance in the conclusions in 82 studies (62%). 102 studies (77%) provided data availability statements and six had data already available. Most studies had industry funding (n = 111 [84.0%]). Oncology trials were more likely to be industry-funded (90.1% vs 64.5%, P = .001), to have industry-affiliated analysts (43.6% vs 22.6%, P = .036), and to favor industry-sponsored interventions (83.2% vs 58.1% P = .004). When compared to other trials, genetic and -omics trials were more likely to be funded by industry (84% vs 63.9%, P < .001) and tended to be less likely to have full protocols (P = .018) and statistical plans (P = .04) available. CONCLUSION Our study highlights the current underutilization of genetic and -omics technologies beyond testing for cancer mutations. Industry involvement in these trials appears to be more substantial and transparency is more limited, raising concerns about potential bias.
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Affiliation(s)
- Luigi Russo
- Section of Hygiene, Department of Life Sciences and Public Health, Universita Cattolica del Sacro Cuore, Rome, Italy
| | - Leonardo M Siena
- Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy
| | - Sara Farina
- Section of Hygiene, Department of Life Sciences and Public Health, Universita Cattolica del Sacro Cuore, Rome, Italy
| | - Roberta Pastorino
- Section of Hygiene, Department of Life Sciences and Public Health, Universita Cattolica del Sacro Cuore, Rome, Italy; Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
| | - Stefania Boccia
- Section of Hygiene, Department of Life Sciences and Public Health, Universita Cattolica del Sacro Cuore, Rome, Italy; Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy
| | - John P A Ioannidis
- Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA; Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, USA; Department of Biomedical Data Science, Stanford University School of Medicine, Stanford, CA, USA; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.
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Sherry AD, Corrigan KL, Kouzy R, Abi Jaoude J, Yang Y, Patel RR, Totten DJ, Newman NB, Das P, Taniguchi C, Minsky B, Snyder RA, David Fuller C, Ludmir E. Prevalence, trends, and characteristics of trials investigating local therapy in contemporary phase 3 clinical cancer research. Cancer 2023; 129:3430-3438. [PMID: 37382235 PMCID: PMC11349322 DOI: 10.1002/cncr.34929] [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: 01/27/2023] [Revised: 04/11/2023] [Accepted: 05/05/2023] [Indexed: 06/30/2023]
Abstract
BACKGROUND Although most patients with cancer are treated with local therapy (LT), the proportion of late-phase clinical trials investigating local therapeutic interventions is unknown. The purpose of this study was to determine the proportion, characteristics, and trends of phase 3 cancer clinical trials assessing the therapeutic value of LT over time. METHODS This was a cross-sectional analysis of interventional randomized controlled trials in oncology published from 2002 through 2020 and registered on ClinicalTrials.gov. Trends and characteristics of LT trials were compared to all other trials. RESULTS Of 1877 trials screened, 794 trials enrolling 584,347 patients met inclusion criteria. A total of 27 trials (3%) included a primary randomization assessing LT compared with 767 trials (97%) investigating systemic therapy or supportive care. Annual increase in the number of LT trials (slope [m] = 0.28; 95% confidence interval [CI], 0.15-0.39; p < .001) was outpaced by the increase of trials testing systemic therapy or supportive care (m = 7.57; 95% CI, 6.03-9.11; p < .001). LT trials were more often sponsored by cooperative groups (22 of 27 [81%] vs. 211 of 767 [28%]; p < .001) and less often sponsored by industry (5 of 27 [19%] vs. 609 of 767 [79%]; p < .001). LT trials were more likely to use overall survival as primary end point compared to other trials (13 of 27 [48%] vs. 199 of 767 [26%]; p = .01). CONCLUSIONS In contemporary late-phase oncology research, LT trials are increasingly under-represented, under-funded, and evaluate more challenging end points compared to other modalities. These findings strongly argue for greater resource allocation and funding mechanisms for LT clinical trials. PLAIN LANGUAGE SUMMARY Most people who have cancer receive treatments directed at the site of their cancer, such as surgery or radiation. We do not know, however, how many trials test surgery or radiation compared to drug treatments (that go all over the body). We reviewed trials testing the most researched strategies (phase 3) completed between 2002 and 2020. Only 27 trials tested local treatments like surgery or radiation compared to 767 trials testing other treatments. Our study has important implications for funding research and understanding cancer research priorities.
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Affiliation(s)
- Alexander D. Sherry
- Division of Radiation Oncology, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
| | - Kelsey L. Corrigan
- Division of Radiation Oncology, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
| | - Ramez Kouzy
- Division of Radiation Oncology, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
| | - Joseph Abi Jaoude
- Division of Radiation Oncology, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
| | - Yumeng Yang
- Department of Biomedical Informatics, The University of Texas Health Science Center at Houston, Houston, Texas, USA
| | - Roshal R. Patel
- Division of Radiation Oncology, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
- Department of Radiation Oncology, Memorial Sloan–Kettering Cancer Center, New York, New York, USA
| | - Douglas J. Totten
- Department of Otolaryngology–Head and Neck Surgery, Indiana University School of Medicine, Indianapolis, Indiana, USA
| | - Neil B. Newman
- Department of Radiation Oncology, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA
| | - Prajnan Das
- Division of Radiation Oncology, Department of Gastrointestinal Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
| | - Cullen Taniguchi
- Division of Radiation Oncology, Department of Gastrointestinal Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
- Division of Radiation Oncology, Department of Experimental Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
| | - Bruce Minsky
- Division of Radiation Oncology, Department of Gastrointestinal Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
| | - Rebecca A. Snyder
- Division of Surgery, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
- Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
| | - C. David Fuller
- Division of Radiation Oncology, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
| | - Ethan Ludmir
- Division of Radiation Oncology, Department of Gastrointestinal Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
- Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
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Maia FHDA, Rozman LM, Carvalho HDA, de Soárez PC. Systematic review of economic evaluations on stereotactic ablative radiotherapy (SABR) compared to other radiotherapy techniques or surgical procedures for early-stage non-small cell lung cancer. Cost Eff Resour Alloc 2023; 21:4. [PMID: 36647118 PMCID: PMC9841623 DOI: 10.1186/s12962-023-00415-1] [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: 08/07/2022] [Accepted: 01/03/2023] [Indexed: 01/18/2023] Open
Abstract
BACKGROUND Stereotactic ablative radiotherapy (SABR) is recommended as first-choice treatment to inoperable early-stage non-small cell lung cancer (NSCLC). However, it is not widely adopted in developing countries, and its cost-effectiveness is unclear. We aimed to perform a systematic review of full economic evaluations (EE) that compared SABR with other radiotherapy or surgical procedures to assess the results and methodological approach. METHODS The protocol was registered on PROSPERO (CRD42021241640). We included full EE studies with early-stage NSCLC in which one group was submitted to SABR. Studies that were partial EE, included advanced NSCLC or other neoplasm were excluded. We performed the last search on June 2021 in Medline, EMBASE and other databases. The reporting quality were assessed by CHEERS checklist. The main characteristics of each study were tabulated, and the results were presented by a narrative synthesis. RESULTS We included nine studies. Three compared radiotherapy techniques, in which SABR was found to be dominant or cost-effective. Six compared SABR with surgery, and in this group, there was not a unanimous decision. All included only direct healthcare costs but varied about categories included. The parameters used in the model-based studies were highly heterogeneous using mixed data from various sources. The items properly reported varied from 29 to 67%. CONCLUSIONS The studies were all from developed countries and lacked in reporting quality. We recommend that developing countries produce their own studies. More strict alignment to reporting guidelines and use of robust evidence as model parameters are also advised.
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Affiliation(s)
- Fernando Henrique de Albuquerque Maia
- grid.11899.380000 0004 1937 0722Departamento de Medicina Preventiva, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av Dr Arnaldo 455, Sao Paulo, SP CEP: 01246903 Brazil ,grid.450640.30000 0001 2189 2026National Institute of Science and Technology for Health Technology Assessment (IATS), CNPq/Brazil, Brasília, Brazil
| | - Luciana Martins Rozman
- grid.11899.380000 0004 1937 0722Departamento de Medicina Preventiva, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av Dr Arnaldo 455, Sao Paulo, SP CEP: 01246903 Brazil ,grid.450640.30000 0001 2189 2026National Institute of Science and Technology for Health Technology Assessment (IATS), CNPq/Brazil, Brasília, Brazil
| | - Heloisa de Andrade Carvalho
- grid.11899.380000 0004 1937 0722Departamento de Radiologia E Oncologia, Divisao de Radioterapia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP Brazil
| | - Patrícia Coelho de Soárez
- grid.11899.380000 0004 1937 0722Departamento de Medicina Preventiva, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av Dr Arnaldo 455, Sao Paulo, SP CEP: 01246903 Brazil ,grid.450640.30000 0001 2189 2026National Institute of Science and Technology for Health Technology Assessment (IATS), CNPq/Brazil, Brasília, Brazil
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Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, Caulley L, Chaiyakunapruk N, Greenberg D, Loder E, Mauskopf J, Mullins CD, Petrou S, Pwu RF, Staniszewska S. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2022; 25:10-31. [PMID: 35031088 DOI: 10.1016/j.jval.2021.10.008] [Citation(s) in RCA: 395] [Impact Index Per Article: 131.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 11/03/2021] [Indexed: 05/22/2023]
Abstract
Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces the previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, and the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as healthcare, public health, education, and social care). This Explanation and Elaboration Report presents the new CHEERS 2022 28-item checklist with recommendations and explanation and examples for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals and the peer reviewers and editors assessing them for publication. Nevertheless, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, given that there is an increasing emphasis on transparency in decision making.
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Affiliation(s)
- Don Husereau
- University of Ottawa, School of Epidemiology and Public Health, Ottawa, Ontario, Canada and Institute of Health Economics, Edmonton, Alberta, Canada (Husereau).
| | | | - Federico Augustovski
- Health Technology Assessment and Health Economics Department of the Institute for Clinical Effectiveness and Health Policy (IECS- CONICET), Buenos Aires; University of Buenos Aires, Buenos Aires; CONICET (National Scientific and Technical Research Council), Buenos Aires, Argentina
| | - Esther de Bekker-Grob
- Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands
| | - Andrew H Briggs
- London School of Hygiene and Tropical Medicine, London, England, UK
| | | | - Lisa Caulley
- Department of Otolaryngology - Head & Neck Surgery, University of Ottawa, Ontario, Canada; Clinical Epidemiology Program and Center for Journalology, Ottawa Hospital Research Institute, Ontario, Canada; Department of Epidemiology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands
| | - Nathorn Chaiyakunapruk
- Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, USA
| | - Dan Greenberg
- Department of Health Policy and Management, School of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er-Sheva, Israel
| | - Elizabeth Loder
- Harvard Medical School, Boston, MA, USA; The BMJ, London, UK
| | - Josephine Mauskopf
- RTI Health Solutions, RTI International, Research Triangle Park, NC, USA
| | - C Daniel Mullins
- School of Pharmacy, University of Maryland Baltimore, Baltimore, MD, USA
| | - Stavros Petrou
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
| | - Raoh-Fang Pwu
- National Hepatitis C Program Office, Ministry of Health and Welfare, Taipei City, Taiwan
| | - Sophie Staniszewska
- Warwick Research in Nursing, University of Warwick Warwick Medical School, Warwick, UK
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Rahman MW, Trivedi NU, Bach PB, Mitchell AP. Increasing Financial Payments From Industry to Medical Oncologists in the United States, 2014-2017. J Natl Compr Canc Netw 2021; 20:jnccn20125. [PMID: 34965511 PMCID: PMC9309756 DOI: 10.6004/jnccn.2021.7024] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2020] [Accepted: 02/02/2021] [Indexed: 11/17/2022]
Abstract
BACKGROUND Personal payments from the pharmaceutical industry to US physicians are common and are associated with changes in physicians' clinical practice and interpretation of clinical trial results. We assessed temporal trends in industry payments to oncologists, with particular emphasis on payments to authors of oncology clinical practice guideline and on payments related to immunotherapy drugs. METHODS We included US physicians with active National Plan and Provider Enumeration System records and demographic data available in the Centers for Medicare & Medicaid Services Physician Compare system who had a specialty type of medical oncology or general internal medicine. Medical oncologists serving on NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Panels were identified manually. Industry payments, and the subset associated with PD-1/PD-L1 drugs, were identified in Open Payments, the federal repository of all transactions of financial value from industry to physicians and teaching hospitals, from 2014 to 2017. RESULTS There were 13,087 medical oncologists and 85,640 internists who received payments. The mean, annual, per-physician value of payments to oncologists increased from $3,811 in 2014 to $5,854 in 2017, and from $444 to $450 for internists; the median payment increased from $152 to $199 for oncologists and remained at $0 for internists. Oncologists who served on NCCN Guidelines Panels received a greater value in payments and experienced a greater relative increase: mean payments increased from $10,820 in 2014 to $18,977 in 2017, and median payments increased from $500 to $1,366. Among companies marketing PD-1/PD-L1 drugs, mean annual per-oncologist payments associated with PD-1/PD-L1 drugs increased from $28 to $773. Total per-oncologist payments from companies marketing PD-1/PD-L1 drugs experienced a 165% increase from 2014 to 2017, compared with a 31% increase among similar companies not marketing PD-1/PD-L1 drugs. CONCLUSIONS Pharmaceutical industry payments increased for US oncologists from 2014 to 2017 more than for general internists. The increase was greater among oncologists contributing to clinical practice guidelines and among pharmaceutical companies marketing PD-1/PD-L1 drugs. The increasing flow of money from industry to US oncologists supports ongoing concern regarding commercial interests in guideline development and clinical decision-making.
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Affiliation(s)
- Mohammed W Rahman
- 1Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Niti U Trivedi
- 1Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Peter B Bach
- 1Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Aaron P Mitchell
- 1Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
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Campolina AG, Suzumura EA, Hong QN, de Soárez PC. Multicriteria decision analysis in health care decision in oncology: a systematic review. Expert Rev Pharmacoecon Outcomes Res 2021; 22:365-380. [PMID: 34913775 DOI: 10.1080/14737167.2022.2019580] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
Abstract
INTRODUCTION Multicriteria decision analysis (MCDA) has been used to inform health decisions in health technology assessments (HTA) processes. This is particularly important to complex treatment decisions in oncology. AREAS COVERED Five databases (PubMed, EMBASE, LILACS, Web of Science and CRD's NHS Economic Evaluation Database) were searched for studies comparing health technologies in oncology, involving the concept MCDA. The ISPOR MCDA Good Practices Guidelines were used to assess the reporting quality. Study selection, appraisal, and data extraction were performed by two reviewers. Fifteen studies were included. The main decision problem was related to health technology assessment of cancer treatments. Clinicians and public health experts were the most frequent stakeholders. The most frequently included criteria comprised therapeutic benefit, and socio-economic impact. Value measurement approach, direct rating techniques, and additive model for aggregation were used in most studies. Uncertainty analysis revealed the impact of posology and costs on the studies' results. All studies showed some level of overlapping decision criteria. EXPERT OPINION There is considerable diversity of methods in MCDA for healthcare decision-making in oncology. The evidence presented can serve as a resource when considering which stakeholders, criteria, and techniques to include in future MCDA studies in oncology.
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Affiliation(s)
- Alessandro Gonçalves Campolina
- Departamento de Medicina Preventiva, Faculdade de Medicina Fmusp, Universidade de Sao Paulo, Sao Paulo, Brazil.,Centro de Investigação Translacional Em Oncologia, Instituto Do Cancer Do Estado de Sao Paulo, Faculdade de Medicina Fmusp, Universidade de Sao Paulo, Sao Paulo, Brazil
| | - Erica Aranha Suzumura
- Departamento de Medicina Preventiva, Faculdade de Medicina Fmusp, Universidade de Sao Paulo, Sao Paulo, Brazil
| | - Quan Nha Hong
- EPPI-Centre, UCL Social Research Institute, University College London, London, UK
| | - Patrícia Coelho de Soárez
- Departamento de Medicina Preventiva, Faculdade de Medicina Fmusp, Universidade de Sao Paulo, Sao Paulo, Brazil
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Ball G, Levine M, Thabane L, Tarride JE. Onwards and Upwards: A Systematic Survey of Economic Evaluation Methods in Oncology. PHARMACOECONOMICS - OPEN 2021; 5:397-410. [PMID: 33893974 PMCID: PMC8333159 DOI: 10.1007/s41669-021-00263-w] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Accepted: 03/17/2021] [Indexed: 06/12/2023]
Abstract
INTRODUCTION The type of methods used in economic evaluations of health technology can lead to results that may influence decisions. Despite the potential impact on decision making, there is very little documentation of methods used in economic evaluation in oncology pertaining to key assumptions and extrapolation methods of survival benefits, especially in terms of survival analysis techniques and methods for extrapolation. OBJECTIVES The primary objectives of this study were to identify, examine, and describe the methods used in economic evaluations in oncology over a 10-year period, while secondary objectives included examining the use of identified methods across different geographic regions. METHODS A systematic search of the published oncology literature was conducted to identify economic evaluations of advanced or metastatic cancers published between 2010 and 2019 using the PUBMED, Ovid MEDLINE, and EMBASE databases. A random sample was taken, and information on type of study, data source, modeling techniques, and survival analysis methods were abstracted and descriptively summarized. RESULTS A total of 8481 abstracts were identified and 76 economic evaluations were abstracted and assessed. Most identified studies were from North America (38%), East Asia (21%), continental Europe (18%), or the UK (16%), and most commonly focused on lung cancer (18%), colorectal cancer (16%), or breast cancer (13%). A large majority of studies were based on data from randomized controlled trials (82%), utilized a cost-utility approach (82%), and took a public healthcare system perspective (83%). Common model structures included Markov (49%) and partitioned survival (17%). Fitted parametric curves were the most commonly used extrapolation method (89%) for overall survival and most often utilized the Weibull distribution (64%). Secondary assessments showed modest regional variation in the use of identified methods, including the use of fitted parametric curves, testing of the proportional hazards assumption, and validation of results. CONCLUSION A majority of papers in the study sample reported basic characteristics of study type, data source used, modeling techniques, and utilization of survival analysis methods. However, greater detail in reporting extrapolation methods, statistical analyses, and validation of results could be potential improvements, especially across regions, in order to support greater consistency in decision making. Future research could document the diffusion of novel modeling techniques into economic evaluation.
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Affiliation(s)
- Graeme Ball
- Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
| | - Mitch Levine
- Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada
- The Research Institute of St. Joe's Hamilton, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada
| | - Lehana Thabane
- Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada
- The Research Institute of St. Joe's Hamilton, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada
| | - Jean-Eric Tarride
- Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada
- The Research Institute of St. Joe's Hamilton, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada
- McMaster Chair in Health Technology Management, McMaster University, Hamilton, ON, Canada
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Masterson L, Howard J, Gonzalez‐Cruz J, Jackson C, Barnett C, Overton L, Liu H, Ladwa R, Simpson F, McGrath M, Wallwork B, Jones T, Ottensmeier C, Chua ML, Perry C, Khanna R, Panizza B, Porceddu S, Lechner M. Immune checkpoint inhibitors in advanced nasopharyngeal carcinoma: Beyond an era of chemoradiation? Int J Cancer 2020; 146:2305-2314. [DOI: 10.1002/ijc.32869] [Citation(s) in RCA: 31] [Impact Index Per Article: 6.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2019] [Revised: 12/11/2019] [Accepted: 12/12/2019] [Indexed: 12/11/2022]
Affiliation(s)
- Liam Masterson
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
- Department of ENTUniversity of Cambridge Cambridge United Kingdom
| | | | | | - Christopher Jackson
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
| | - Catherine Barnett
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
| | - Lewis Overton
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
| | - Howard Liu
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
| | - Rahul Ladwa
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
| | - Fiona Simpson
- Diamantina Institute, University of Queensland Woolloongabba QLD Australia
| | - Margie McGrath
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
| | - Ben Wallwork
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
- Faculty of MedicineUniversity of Queensland St. Lucia Australia
| | - Terry Jones
- Liverpool Head & Neck CentreUniversity of Liverpool Liverpool United Kingdom
| | | | - Melvin L.K. Chua
- Divisions of Radiation Oncology & Medical Science, National Cancer Centre Singapore Singapore
| | - Chris Perry
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
- Faculty of MedicineUniversity of Queensland St. Lucia Australia
| | - Rajiv Khanna
- QIMR Berghofer Medical Research Institute Brisbane City QLD Australia
| | - Benedict Panizza
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
- Faculty of MedicineUniversity of Queensland St. Lucia Australia
| | - Sandro Porceddu
- Department of Head & Neck OncologyPrincess Alexandra Hospital Brisbane Australia
- Faculty of MedicineUniversity of Queensland St. Lucia Australia
| | - Matt Lechner
- UCL Cancer InstituteUniversity College London London United Kingdom
- Barts Health NHS Trust London United Kingdom
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Liang L, Bin-Chia Wu D, Aziz MIA, Wong R, Sim D, Leong KTG, Wei YQ, Tan D, Ng K. Reply: Cost-effectiveness of sacubitril/valsartan versus enalapril in patients with heart failure and reduced ejection fraction. J Med Econ 2018; 21:1148-1149. [PMID: 30255725 DOI: 10.1080/13696998.2018.1528979] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/28/2022]
Affiliation(s)
- Lin Liang
- a Agency for Care Effectiveness , Ministry of Health , Singapore
| | | | | | - Raymond Wong
- b Department of Cardiology , National University Heart Centre , Singapore
| | - David Sim
- c Department of Cardiology , National Heart Centre , Singapore
| | | | - Yong Quek Wei
- e Department of Cardiology , Tan Tock Seng Hospital , Singapore
| | - Doreen Tan
- f Department of Pharmacy , Khoo Teck Puat Hospital , Singapore
| | - Kwong Ng
- a Agency for Care Effectiveness , Ministry of Health , Singapore
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De Jesus-Morales K, Prasad V. Closed Financial Loops: When They Happen in Government, They're Called Corruption; in Medicine, They're Just a Footnote. Hastings Cent Rep 2018; 47:9-14. [PMID: 28543414 DOI: 10.1002/hast.700] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
Many physicians are involved in relationships that create tension between a physician's duty to work in her patients' best interest at all times and her financial arrangement with a third party, most often a pharmaceutical manufacturer, whose primary goal is maximizing sales or profit. Despite the prevalence of this threat, in the United States and globally, the most common reaction to conflicts of interest in medicine is timid acceptance. There are few calls for conflicts of interest to be banned, and, to our knowledge, no one calls for conflicted practitioners to be reprimanded. Contrast our attitudes in medicine with public attitudes toward financial conflicts among government employees. When enforcement of rules against conflict of interest slackens in the public sector, news organizations investigate and publish their criticism. Yet even when doctors are quoted in the media promoting specific drugs, their personal financial ties to the drug maker are rarely mentioned. Policies for governmental employees are strict, condemnation is strong, and criminal statutes exist (allowing for corruption charges). Yet the evidence that conflict is problematic is, if anything, stronger in medicine than in the public sector. Policies against conflicts of interest in medicine should be at least as strong as those already existing in the public sector.
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4-Acetyl-Antroquinonol B Suppresses SOD2-Enhanced Cancer Stem Cell-Like Phenotypes and Chemoresistance of Colorectal Cancer Cells by Inducing hsa-miR-324 re-Expression. Cancers (Basel) 2018; 10:cancers10080269. [PMID: 30103475 PMCID: PMC6116152 DOI: 10.3390/cancers10080269] [Citation(s) in RCA: 23] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/12/2018] [Revised: 08/04/2018] [Accepted: 08/07/2018] [Indexed: 01/07/2023] Open
Abstract
Background: Colorectal cancer (CRC) remains a leading cause of cancer-related morbidity and mortality in both sexes globally. This is not unconnected with the heterogeneity and plasticity of CRC stem cells (CRC-SCs) which stealthily exploit the niche-related and (epi)genetic factors to facilitate metastasis, chemoresistance, tumor recurrence, and disease progression. Despite the accumulating evidence of the role of dysregulated microRNAs in malignancies, the therapeutic efficacy of pharmacological-targeting of CRC-SC-associated microRNAs is relatively under-explored. Experimental approach: In this present study, we employed relatively new bioinformatics approaches, analyses of microarray data, Western blot, real-time polymerase chain reaction (RT-PCR), and functional assays to show that hsa-miR-324-5p expression is significantly suppressed in CRC cells, and inversely correlates with the aberrant expression of SOD2. Results: This converse hsa-miR-324-5p/SOD2 relationship is associated with enhanced oncogenicity, which is effectively inhibited by 4-acetylantroquinonol B (4-AAQB), as evidenced by inhibited cell viability and proliferation, as well as attenuated migration, invasion, and clonogenicity in 4-AAQB-treated DLD1 and HCT116 cells. Interestingly, 4-AAQB did not affect the viability and proliferation of normal colon cells. We also showed that 4-AAQB-induced re-expression of hsa-miR-324-5p, akin to short-interfering RNA, reduced SOD2 expression, correlates with the concurrent down-regulation of SOD2, N-cadherin, vimentin, c-Myc, and BcL-xL2, with concomitant up-regulation of E-cadherin and BAX2 proteins. Enhanced expression of hsa-miR-324-5p in the CRC cells suppressed their tumorigenicity in vitro and in vivo. Additionally, 4-AAQB synergistically potentiates the FOLFOX (folinate (leucovorin), fluorouracil (5FU), and oxaliplatin) anticancer effect by eliciting the re-expression of SOD2-suppressed hsa-miR-324, and inhibiting SOD2-mediated tumorigenicity. Conclusion: Our findings highlight the pre-clinical anti-CSC efficacy of 4-AAQB, with or without FOLFOX in CRC, and suggest a potential novel therapeutic strategy for CRC patients.
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Wang SY, Dang W, Richman I, Mougalian SS, Evans SB, Gross CP. Cost-Effectiveness Analyses of the 21-Gene Assay in Breast Cancer: Systematic Review and Critical Appraisal. J Clin Oncol 2018; 36:1619-1627. [PMID: 29659329 DOI: 10.1200/jco.2017.76.5941] [Citation(s) in RCA: 66] [Impact Index Per Article: 9.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
Purpose Prior studies examining cost effectiveness of the 21-gene assay (Oncotype DX [ODX]) for women with hormone receptor-positive, early-stage breast cancer have yielded disparate results. We aimed to explore why these analyses may have yielded different conclusions. Methods We conducted a systematic literature review of cost-effectiveness analyses (CEAs) of ODX. We examined the extent to which the structure of CEA modeling, the assumptions of the models, and the selection of input parameters influenced cost-effectiveness estimates. We also explored the prevalence of industry funding and whether industry funding was associated with study designs favoring ODX. Results We identified 27 analyses, 15 of which received industry funding. In 18 studies, the clinical characteristics (eg, tumor size and grade) commonly used to make chemotherapy decisions were not incorporated into simulation modeling; thus, these studies would favor ODX being cost effective and might not reflect clinical practice. Most studies ignored the heterogeneous effect of ODX on chemotherapy use; only five studies assumed that ODX would increase chemotherapy use for clinically low-risk patients but decrease chemotherapy use for clinically high-risk patients. No study used population-based joint distributions of ODX recurrence score and tumor characteristics, and 12 studies inappropriately assumed that chemotherapy would increase distant recurrence for the low recurrence score group; both approaches overestimated the benefits of ODX. Industry-funded studies tended to favor ODX; all five studies that reported ODX as being cost saving were industry funded. In contrast, two studies that reported an incremental cost-effectiveness ratio > $50,000 per quality-adjusted life-year were not funded by industry. Conclusion Although a majority of published analyses indicated that ODX is cost effective, they incorporated study designs that can increase the risk of bias.
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Affiliation(s)
- Shi-Yi Wang
- Shi-Yi Wang and Weixiong Dang, Yale University School of Public Health; Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale Cancer Center; and Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale University School of Medicine, New Haven, CT
| | - Weixiong Dang
- Shi-Yi Wang and Weixiong Dang, Yale University School of Public Health; Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale Cancer Center; and Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale University School of Medicine, New Haven, CT
| | - Ilana Richman
- Shi-Yi Wang and Weixiong Dang, Yale University School of Public Health; Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale Cancer Center; and Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale University School of Medicine, New Haven, CT
| | - Sarah S Mougalian
- Shi-Yi Wang and Weixiong Dang, Yale University School of Public Health; Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale Cancer Center; and Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale University School of Medicine, New Haven, CT
| | - Suzanne B Evans
- Shi-Yi Wang and Weixiong Dang, Yale University School of Public Health; Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale Cancer Center; and Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale University School of Medicine, New Haven, CT
| | - Cary P Gross
- Shi-Yi Wang and Weixiong Dang, Yale University School of Public Health; Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale Cancer Center; and Shi-Yi Wang, Ilana Richman, Sarah S. Mougalian, Suzanne B. Evans, and Cary P. Gross, Yale University School of Medicine, New Haven, CT
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Decimoni TC, Leandro R, Rozman LM, Craig D, Iglesias CP, Novaes HMD, de Soárez PC. Systematic Review of Health Economic Evaluation Studies Developed in Brazil from 1980 to 2013. Front Public Health 2018; 6:52. [PMID: 29541630 PMCID: PMC5835950 DOI: 10.3389/fpubh.2018.00052] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/29/2017] [Accepted: 02/09/2018] [Indexed: 11/22/2022] Open
Abstract
BACKGROUND Brazil has sought to use economic evaluation to support healthcare decision-making processes. While a number of health economic evaluations (HEEs) have been conducted, no study has systematically reviewed the quality of Brazilian HEE. The objective of this systematic review was to provide an overview regarding the state of HEE research and to evaluate the number, characteristics, and quality of reporting of published HEE studies conducted in a Brazilian setting. METHODS We systematically searched electronic databases (MEDLINE, EMBASE, Latin American, and Caribbean Literature on Health Sciences Database, Scientific Electronic Library Online, NHS Economic Evaluation Database, health technology assessment Database, Bireme, and Biblioteca Virtual em Saúde Economia da Saúde); citation indexes (SCOPUS, Web of Science), and Sistema de Informação da Rede Brasileira de Avaliação de Tecnologia em Saúde. Partial and full HEEs published between 1980 and 2013 that referred to a Brazilian setting were considered for inclusion. RESULTS In total, 535 studies were included in the review, 36.8% of these were considered to be full HEE. The category of healthcare technologies more frequently assessed were procedures (34.8%) and drugs (28.8%) which main objective was treatment (72.1%). Forty-four percent of the studies reported their funding source and 36% reported a conflict of interest. Overall, the full HEE quality of reporting was satisfactory. But some items were generally poorly reported and significant improvement is required: (1) methods used to estimate healthcare resource use quantities and unit costs, (2) methods used to estimate utility values, (3) sources of funding, and (4) conflicts of interest. CONCLUSION A steady number of HEE have been published in Brazil since 1980. To improve their contribution to inform national healthcare policy efforts need to be made to enhance the quality of reporting of HEEs and promote improvements in the way HEEs are designed, implemented (i.e., using sound methods for HEEs) and reported.
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Affiliation(s)
- Tassia Cristina Decimoni
- Department of Preventive Medicine, Faculty of Medicine, University of São Paulo, São Paulo, Brazil
| | - Roseli Leandro
- Department of Preventive Medicine, Faculty of Medicine, University of São Paulo, São Paulo, Brazil
| | - Luciana Martins Rozman
- Department of Preventive Medicine, Faculty of Medicine, University of São Paulo, São Paulo, Brazil
| | - Dawn Craig
- Institute of Health and Society, Newcastle University, Newcastle, United Kingdom
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Funding source, conflict of interest and positive conclusions in neuro-oncology clinical trials. J Neurooncol 2017; 136:585-593. [DOI: 10.1007/s11060-017-2687-2] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/28/2017] [Accepted: 11/15/2017] [Indexed: 10/18/2022]
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Oliveira MRF, Leandro R, Decimoni TC, Rozman LM, Novaes HMD, De Soárez PC. Systematic Review of Health Economic Evaluations of Diagnostic Tests in Brazil: How accurate are the results? Clinics (Sao Paulo) 2017; 72:499-509. [PMID: 28954010 PMCID: PMC5577617 DOI: 10.6061/clinics/2017(08)08] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/03/2016] [Accepted: 03/06/2017] [Indexed: 12/11/2022] Open
Abstract
The aim of this study is to identify and characterize the health economic evaluations (HEEs) of diagnostic tests conducted in Brazil, in terms of their adherence to international guidelines for reporting economic studies and specific questions in test accuracy reports. We systematically searched multiple databases, selecting partial and full HEEs of diagnostic tests, published between 1980 and 2013. Two independent reviewers screened articles for relevance and extracted the data. We performed a qualitative narrative synthesis. Forty-three articles were reviewed. The most frequently studied diagnostic tests were laboratory tests (37.2%) and imaging tests (32.6%). Most were non-invasive tests (51.2%) and were performed in the adult population (48.8%). The intended purposes of the technologies evaluated were mostly diagnostic (69.8%), but diagnosis and treatment and screening, diagnosis, and treatment accounted for 25.6% and 4.7%, respectively. Of the reviewed studies, 12.5% described the methods used to estimate the quantities of resources, 33.3% reported the discount rate applied, and 29.2% listed the type of sensitivity analysis performed. Among the 12 cost-effectiveness analyses, only two studies (17%) referred to the application of formal methods to check the quality of the accuracy studies that provided support for the economic model. The existing Brazilian literature on the HEEs of diagnostic tests exhibited reasonably good performance. However, the following points still require improvement: 1) the methods used to estimate resource quantities and unit costs, 2) the discount rate, 3) descriptions of sensitivity analysis methods, 4) reporting of conflicts of interest, 5) evaluations of the quality of the accuracy studies considered in the cost-effectiveness models, and 6) the incorporation of accuracy measures into sensitivity analyses.
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Affiliation(s)
- Maria Regina Fernandes Oliveira
- Faculdade de Medicina, Universidade de Brasilia, Campus Universitario Darcy Ribeiro, Brasilia, DF, BR
- Instituto de Avaliacao de Tecnologias em Saude (IATS/CNPq), Porto Alegre, RS, BR
| | - Roseli Leandro
- Departamento de Medicina Preventiva, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR
- Hospital de Transplantes Euryclides de Jesus Zerbini, Sao Paulo, SP, BR
| | - Tassia Cristina Decimoni
- Departamento de Medicina Preventiva, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR
| | - Luciana Martins Rozman
- Departamento de Medicina Preventiva, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR
| | - Hillegonda Maria Dutilh Novaes
- Departamento de Medicina Preventiva, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR
- Instituto de Avaliacao de Tecnologias em Saude (IATS/CNPq), Porto Alegre, RS, BR
| | - Patrícia Coelho De Soárez
- Departamento de Medicina Preventiva, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR
- Instituto de Avaliacao de Tecnologias em Saude (IATS/CNPq), Porto Alegre, RS, BR
- *Corresponding author. E-mail:
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Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L, Cochrane Methodology Review Group. Industry sponsorship and research outcome. Cochrane Database Syst Rev 2017; 2:MR000033. [PMID: 28207928 PMCID: PMC8132492 DOI: 10.1002/14651858.mr000033.pub3] [Citation(s) in RCA: 500] [Impact Index Per Article: 62.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical-industry sponsored studies are more often favorable to the sponsor's product compared with studies with other sources of sponsorship. A similar association between sponsorship and outcomes have been found for device studies, but the body of evidence is not as strong as for sponsorship of drug studies. This review is an update of a previous Cochrane review and includes empirical studies on the association between sponsorship and research outcome. OBJECTIVES To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. SEARCH METHODS In this update we searched MEDLINE (2010 to February 2015), Embase (2010 to February 2015), the Cochrane Methodology Register (2015, Issue 2) and Web of Science (June 2015). In addition, we searched reference lists of included papers, previous systematic reviews and author files. SELECTION CRITERIA Cross-sectional studies, cohort studies, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions. DATA COLLECTION AND ANALYSIS Two assessors screened abstracts and identified and included relevant papers. Two assessors extracted data, and we contacted authors of included papers for additional unpublished data. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether the conclusions agreed with the study results. Two assessors assessed risk of bias of included papers. We calculated pooled risk ratios (RR) for dichotomous data (with 95% confidence intervals (CIs)). MAIN RESULTS Twenty-seven new papers were included in this update and in total the review contains 75 included papers. Industry sponsored studies more often had favorable efficacy results, RR: 1.27 (95% CI: 1.17 to 1.37) (25 papers) (moderate quality evidence), similar harms results RR: 1.37 (95% CI: 0.64 to 2.93) (four papers) (very low quality evidence) and more often favorable conclusions RR: 1.34 (95% CI: 1.19 to 1.51) (29 papers) (low quality evidence) compared with non-industry sponsored studies. Nineteen papers reported on sponsorship and efficacy effect size, but could not be pooled due to differences in their reporting of data and the results were heterogeneous. We did not find a difference between drug and device studies in the association between sponsorship and conclusions (test for interaction, P = 0.98) (four papers). Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment, follow-up and selective outcome reporting. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.25 (95% CI: 1.05 to 1.50) (13 papers), compared with non-industry sponsored studies. In industry sponsored studies, there was less agreement between the results and the conclusions than in non-industry sponsored studies, RR: 0.83 (95% CI: 0.70 to 0.98) (six papers). AUTHORS' CONCLUSIONS Sponsorship of drug and device studies by the manufacturing company leads to more favorable efficacy results and conclusions than sponsorship by other sources. Our analyses suggest the existence of an industry bias that cannot be explained by standard 'Risk of bias' assessments.
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Affiliation(s)
- Andreas Lundh
- Odense University Hospital and University of Southern DenmarkCenter for Evidence‐Based MedicineSdr. Boulevard 29, Entrance 50 (Videncentret)OdenseDenmark5000
| | - Joel Lexchin
- York UniversitySchool of Health Policy and Management121 Walmer RdTorontoONCanadaM5R 2X8
| | - Barbara Mintzes
- The University of SydneyCharles Perkins Centre and Faculty of PharmacyRoom 6W75, 6th FloorThe Hub, Charles Perkins Centre D17SydneyNSWAustralia2006
| | - Jeppe B Schroll
- Herlev HospitalDepartment of Obstetrics and GynaecologyHerlev Ringvej 75HerlevDenmark2730
| | - Lisa Bero
- Charles Perkins Centre and Faculty of Pharmacy, University of Sydney6th Floor (6W76)The University of SydneySydneyNew South Wales 2006Australia
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Li M, Song LH, Yue GGL, Lee JKM, Zhao LM, Li L, Zhou X, Tsui SKW, Ng SSM, Fung KP, Tan NH, Lau CBS. Bigelovin triggered apoptosis in colorectal cancer in vitro and in vivo via upregulating death receptor 5 and reactive oxidative species. Sci Rep 2017; 7:42176. [PMID: 28181527 PMCID: PMC5299840 DOI: 10.1038/srep42176] [Citation(s) in RCA: 43] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2016] [Accepted: 01/05/2017] [Indexed: 12/30/2022] Open
Abstract
Colorectal cancer (CRC) is the third most prevalent cancer and the third highest cancer-related mortality in the United States. Bigelovin, a sesquiterpene lactone isolated from Inula helianthus aquatica, has been proven to induce apoptosis and exhibit anti-inflammatory and anti-angiogenic activities. However, the effects of bigelovin on CRC and underlying mechanisms have not been explored. The present study demonstrated that bigelovin exhibited potent anti-tumor activities against CRC in vitro and in vivo. Bigelovin suppressed cell proliferation and colony formation and induced apoptosis in human colorectal cancer HT-29 and HCT 116 cells in vitro. Results also revealed that bigelovin activated caspases, caused the G2/M cell cycle arrest and induced DNA damage through up-regulation of death receptor (DR) 5 and increase of ROS. In HCT 116 xenograft model, bigelovin treatment resulted in suppression of tumor growth. Bigelovin at 20 mg/kg showed more significant tumor suppression and less side effects than conventional FOLFOX (containing folinic acid, 5-fluorouracil and oxaliplatin) treatment. In addition, in vivo data confirmed that anti-tumor activity of bigelovin in CRC was through induction of apoptosis by up-regulating DR5 and increasing ROS. In conclusion, these results strongly suggested that bigelovin has potential to be developed as therapeutic agent for CRC patients.
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Affiliation(s)
- Mingyue Li
- School of Biomedical Sciences, The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
- Institute of Chinese Medicine, The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
| | - Li-Hua Song
- School of Traditional Chinese Medicines, China Pharmaceutical University, Nanjing 211198, China
| | - Grace Gar-Lee Yue
- Institute of Chinese Medicine, The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
- State Key Laboratory of Phytochemistry and Plant Resources in West China (CUHK), The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
| | - Julia Kin-Ming Lee
- Institute of Chinese Medicine, The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
- State Key Laboratory of Phytochemistry and Plant Resources in West China (CUHK), The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
| | - Li-Mei Zhao
- State Key Laboratory of Phytochemistry and Plant Resources in West China, Kunming Institute of Botany, Chinese Academy of Sciences, Kunming 650201, China
| | - Lin Li
- Department of Surgery, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
| | - Xunian Zhou
- School of Biomedical Sciences, The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
- Institute of Chinese Medicine, The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
| | - Stephen Kwok-Wing Tsui
- School of Biomedical Sciences, The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
| | - Simon Siu-Man Ng
- Department of Surgery, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
| | - Kwok-Pui Fung
- School of Biomedical Sciences, The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
- Institute of Chinese Medicine, The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
- State Key Laboratory of Phytochemistry and Plant Resources in West China (CUHK), The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
| | - Ning-Hua Tan
- School of Traditional Chinese Medicines, China Pharmaceutical University, Nanjing 211198, China
- State Key Laboratory of Phytochemistry and Plant Resources in West China, Kunming Institute of Botany, Chinese Academy of Sciences, Kunming 650201, China
| | - Clara Bik-San Lau
- Institute of Chinese Medicine, The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
- State Key Laboratory of Phytochemistry and Plant Resources in West China (CUHK), The Chinese University of Hong Kong, Shatin New Territories, Hong Kong
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Al-Badriyeh D, Alameri M, Al-Okka R. Cost-effectiveness research in cancer therapy: a systematic review of literature trends, methods and the influence of funding. BMJ Open 2017; 7:e012648. [PMID: 28131999 PMCID: PMC5278265 DOI: 10.1136/bmjopen-2016-012648] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/16/2016] [Revised: 11/13/2016] [Accepted: 12/14/2016] [Indexed: 12/02/2022] Open
Abstract
OBJECTIVE To perform a first-time analysis of the cost-effectiveness (CE) literature on chemotherapies, of all types, in cancer, in terms of trends and change over time, including the influence of industry funding. DESIGN Systematic review. SETTING A wide range of cancer-related research settings within healthcare, including health systems, hospitals and medical centres. PARTICIPANTS All literature comparative CE research of drug-based cancer therapies in the period 1986 to 2015. PRIMARY AND SECONDARY OUTCOME MEASURES Primary outcomes are the literature trends in relation to journal subject category, authorship, research design, data sources, funds and consultation involvement. An additional outcome measure is the association between industry funding and study outcomes. ANALYSIS Descriptive statistics and the χ2, Fisher exact or Somer's D tests were used to perform non-parametric statistics, with a p value of <0.05 as the statistical significance measure. RESULTS Total 574 publications were analysed. The drug-related CE literature expands over time, with increased publishing in the healthcare sciences and services journal subject category (p<0.001). The retrospective data collection in studies increased over time (p<0.001). The usage of prospective data, however, has been decreasing (p<0.001) in relation to randomised clinical trials (RCTs), but is unchanging for non-RCT studies. The industry-sponsored CE studies have especially been increasing (p<0.001), in contrast to those sponsored by other sources. While paid consultation involvement grew throughout the years, the declaration of funding for this is relatively limited. Importantly, there is evidence that industry funding is associated with favourable result to the sponsor (p<0.001). CONCLUSIONS This analysis demonstrates clear trends in how the CE cancer research is presented to the practicing community, including in relation to journals, study designs, authorship and consultation, together with increased financial sponsorship by pharmaceutical industries, which may be more influencing study outcomes than other funding sources.
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Affiliation(s)
| | - Marwah Alameri
- School of Pharmacy, University College London, London, UK
| | - Randa Al-Okka
- National Center for Cancer Care and Research, Hamad Medical Corporation, Doha, Qatar
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Sartori AMC, Rozman LM, Decimoni TC, Leandro R, Novaes HMD, de Soárez PC. A systematic review of health economic evaluations of vaccines in Brazil. Hum Vaccin Immunother 2017; 13:1-12. [PMID: 28129026 DOI: 10.1080/21645515.2017.1282588] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022] Open
Abstract
BACKGROUND In Brazil, since 2005, the Ministry of Health requires Health Economic Evaluation (HEE) of vaccines for introduction into the National Immunization Program. OBJECTIVES To describe and analyze the full HEE on vaccines conducted in Brazil from 1980 to 2013. METHODS Systematic review of the literature. We searched multiple databases. Two researchers independently selected the studies and extracted the data. The methodological quality of individual studies was evaluated using CHEERS items. RESULTS Twenty studies were reviewed. The most evaluated vaccines were pneumococcal (25%) and HPV (15%). The most used types of HEE were cost-effectiveness analysis (45%) and cost-utility analysis (20%). The research question and compared strategies were stated in all 20 studies and the target population was clear in 95%. Nevertheless, many studies did not inform the perspective of analysis or data sources. CONCLUSIONS HEE of vaccines in Brazil has increased since 2008. However, the studies still have methodological deficiencies.
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Affiliation(s)
- Ana Marli Christovam Sartori
- a Departamento de Moléstias Infecciosas e Parasitárias , Faculdade de Medicina, Universidade de São Paulo , São Paulo , Brazil
| | - Luciana Martins Rozman
- b Departamento de Medicina Preventiva , Faculdade de Medicina, Universidade de São Paulo , São Paulo , Brazil
| | - Tassia Cristina Decimoni
- b Departamento de Medicina Preventiva , Faculdade de Medicina, Universidade de São Paulo , São Paulo , Brazil
| | - Roseli Leandro
- b Departamento de Medicina Preventiva , Faculdade de Medicina, Universidade de São Paulo , São Paulo , Brazil
| | | | - Patrícia Coelho de Soárez
- b Departamento de Medicina Preventiva , Faculdade de Medicina, Universidade de São Paulo , São Paulo , Brazil
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Catalá-López F, Ridao M. [Potential sponsorship bias in cost-effectiveness analyses of healthcare interventions: A cross-sectional analysis]. Aten Primaria 2017; 49:335-342. [PMID: 28062088 PMCID: PMC6875970 DOI: 10.1016/j.aprim.2016.08.001] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2016] [Revised: 08/01/2016] [Accepted: 08/12/2016] [Indexed: 11/30/2022] Open
Abstract
Objetivo Examinar la relación entre la fuente de financiación de los análisis coste-efectividad de intervenciones sanitarias publicados en España y las conclusiones de los estudios. Diseño Estudio descriptivo transversal. Emplazamiento Bases de datos de literatura científica (hasta diciembre de 2014). Participantes (unidad de análisis) Cohorte de análisis coste-efectividad de intervenciones sanitarias publicados en España entre 1989-2014 (n = 223) que presentaran como medida de resultado los años de vida ajustados por calidad (AVAC). Mediciones principales Se establecieron relaciones entre las conclusiones cualitativas de los estudios y el tipo de fuente de financiación utilizando la prueba exacta de Fisher en tablas de contingencia. Se exploraron las distribuciones de las estimaciones de las razones coste-efectividad incremental por fuente de financiación en relación a umbrales hipotéticos de disposición a pagar entre 30.000-50.000 € por AVAC. Resultados Un total de 136 (61,0%) estudios fueron financiados por la industria. Los estudios financiados por la industria eran menos propensos a presentar conclusiones desfavorables o neutrales que los estudios no financiados por la industria (2,2% frente al 23,0%; p < 0,0001), fundamentalmente en los estudios que evaluaban fármacos (0,9% frente al 21,4%; p < 0,0001). Las razones coste-efectividad incremental en los estudios financiados por la industria eran más propensas a situarse por debajo de los umbrales hipotéticos de disposición a pagar de 30.000 € (73,8% frente al 56,3%; p < 0,0001) y 50.000 € (89,4% frente al 68,2%; p < 0,0001) por AVAC. Conclusiones El presente estudio revela un potencial sesgo de patrocinio en los análisis coste-efectividad. Los estudios financiados por la industria podrían estar favoreciendo el perfil de eficiencia de sus productos.
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Affiliation(s)
- Ferrán Catalá-López
- Departamento de Medicina, Universidad de Valencia/Instituto de Investigación Sanitaria INCLIVA y CIBERSAM, Valencia, España; Fundación Instituto de Investigación en Servicios de Salud, Valencia, España; Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), Ottawa, Ontario, Canadá.
| | - Manuel Ridao
- Instituto Aragonés de Ciencias de la Salud (I+CS), Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Zaragoza, España; FISABIO-Salud Pública, Valencia, España
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Woersching AL, Borrego ME, Raisch DW. Assessing the Quality of Economic Evaluations of FDA Novel Drug Approvals: A Systematic Review. Ann Pharmacother 2016; 50:1028-1040. [PMID: 27489087 DOI: 10.1177/1060028016662893] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
Abstract
OBJECTIVE To systematically review and assess the quality of the novel drugs' economic evaluation literature in print during the drugs' early commercial availability following US regulatory approval. DATA SOURCES MEDLINE and the United Kingdom National Health Service Economic Evaluation Database were searched from 1946 through December 2011 for economic evaluations of the 50 novel drugs approved by the FDA in 2008 and 2009. STUDY SELECTION AND DATA EXTRACTION The inclusion criteria were English-language, peer-reviewed, original economic evaluations (cost-utility, cost-effectiveness, cost-minimization, and cost-benefit analyses). We extracted and analyzed data from 36 articles considering 19 of the 50 drugs. Two reviewers assessed each publication's quality using the Quality of Health Economic Studies (QHES) instrument and summarized study quality on a 100-point scale. DATA SYNTHESIS Study quality had a mean of 70.0 ± 16.2 QHES points. The only study characteristics associated with QHES score (with P < 0.05) were having used modeling or advanced statistics, 75.1 versus 61.9 without; using quality-adjusted life years as an outcome, 75.9 versus 64.7 without; and cost-utility versus cost-minimization analysis, 75.9 versus 58.7. Studies most often satisfied quality aspects about stating study design choices and least often satisfied aspects about justifying design choices. CONCLUSION The reviewed literature considered a minority of the 2008-2009 novel drugs and had mixed study quality. Cost-effectiveness stakeholders might benefit from efforts to improve the quality and quantity of literature examining novel drugs. Editors and reviewers may support quality improvement by stringently imposing economic evaluation guidelines about justifying study design choices.
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Guy JB, Vallard A, Espenel S, Langrand-Escure J, Trone JC, Méry B, Ben Mrad M, Diao P, Mattevi C, Chargari C, Magné N. Conflict of interests for radiation oncologists: Harnessing disclosures from policy to reality. Cancer Radiother 2016; 20:176-80. [PMID: 27020716 DOI: 10.1016/j.canrad.2015.12.003] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/01/2015] [Revised: 12/01/2015] [Accepted: 12/02/2015] [Indexed: 11/27/2022]
Abstract
PURPOSE An increasing attention is being paid to disclosures of conflicts of interests in the field of oncology. The purpose of this study was to examine how radiation oncologists report their conflicts of interests with pharmaceutical or technology industries. MATERIALS AND METHODS We collected the data of conflicts of interests disclosures in the abstract books from the annual 2012 and 2013 meetings of the American Society for Radiation Oncology (ASTRO) in Miami (FL, USA), and in Atlanta (GA, USA), respectively. Geographic origins of abstracts as well other factors were examined. RESULTS We identified a total of 4219 abstracts published in the past two years. The total number of involved authors was of 28,283. All of the published abstracts had conflicts of interests disclosures. Amongst them, 563 abstracts (13.4%) reported at least one potential conflict of interests, in which 1264 (4.5%) declared a potential conflict of interests in their disclosures. Geographic distribution of abstracts with financial relationship was as following: 67.9%, 15.5%, 7.7% and 7.7% for USA, Europe, Asia/Pacifica, and Canada, respectively. Abstracts with conflict of interest originated from North America in 75.6% of cases. USA distribution was 70.6% and 29.4% for Eastern and Western, respectively. CONCLUSIONS The proportion of physicians declaring financial conflicts of interests remains extremely low, whichever geographic area authors are from. In comparison to the rest of the world, the US proved itself better at declaring potential links. Changes in medical culture and education could represent a significant step to improve the process of revealing conflicts of interest in medical journal as well as in international meetings.
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Affiliation(s)
- J-B Guy
- Department of Radiation Oncology, centre Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France
| | - A Vallard
- Department of Radiation Oncology, centre Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France
| | - S Espenel
- Department of Radiation Oncology, centre Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France
| | - J Langrand-Escure
- Department of Radiation Oncology, centre Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France
| | - J-C Trone
- Department of Radiation Oncology, centre Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France
| | - B Méry
- Department of Medical Oncology, centre Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France
| | - M Ben Mrad
- Department of Radiation Oncology, centre Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France
| | - P Diao
- Department of Radiation Oncology, centre Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France
| | - C Mattevi
- Department of Radiation Oncology, centre Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France
| | - C Chargari
- Department of Radiation Oncology, hôpital d'instruction des armées du Val-de-Grâce, boulevard de Port-Royal, 75013 Paris, France
| | - N Magné
- Department of Radiation Oncology, centre Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
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de Paiva Haddad LB, Decimoni TC, Turri JA, Leandro R, de Soárez PC. Economic evaluations in gastroenterology in Brazil: A systematic review. World J Gastrointest Pharmacol Ther 2016; 7:162-70. [PMID: 26855823 PMCID: PMC4734950 DOI: 10.4292/wjgpt.v7.i1.162] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/14/2015] [Revised: 11/13/2015] [Accepted: 12/01/2015] [Indexed: 02/06/2023] Open
Abstract
AIM To systematically review economic evaluations in gastroenterology, relating to Brazil, published between 1980 and 2013. METHODS We selected full and partial economic evaluations from among those retrieved by searching the following databases: MEDLINE (PubMed); Excerpta Medica; the Latin American and Caribbean Health Sciences Literature database; the Scientific Electronic Library Online; the database of the Centre for Reviews and Dissemination; the National Health Service (NHS) Economic Evaluation Database; the NHS Health Technology Assessment database; the Health Economics database of the Brazilian Virtual Library of Health; Scopus; Web of Science; and the Brazilian Network for the Evaluation of Health Technologies. Two researchers, working independently, selected the studies and extracted the data. RESULTS We identified 535 health economic evaluations relating to Brazil and published in the 1980-2013 period. Of those 535 articles, only 40 dealt with gastroenterology. Full and partial economic evaluations respectively accounted for 23 (57.5%) and 17 (42.5%) of the 40 studies included. Among the 23 full economic evaluations, there were 11 cost-utility analyses, seven cost-effectiveness analyses, four cost-consequence analyses, and one cost-minimization analysis. Of the 40 studies, 25 (62.5%) evaluated medications; 7 (17.5%) evaluated procedures; and 3 (7.5%) evaluated equipment. Most (55%) of the studies were related to viral hepatitis, and most (63.4%) were published after 2010. Other topics included gastrointestinal cancer, liver transplantation, digestive diseases and hernias. Over the 33-year period examined, the number of such economic evaluations relating to Brazil, especially of those evaluating medications for the treatment of hepatitis, increased considerably. CONCLUSION Further studies are needed in order to ensure that expenditures on health care in Brazil are made as fairly and efficiently as possible.
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Differences in Funding Sources of Phase III Oncology Clinical Trials by Treatment Modality and Cancer Type. Am J Clin Oncol 2014; 40:312-317. [PMID: 25374144 DOI: 10.1097/coc.0000000000000152] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVES Given the limited resources available to conduct clinical trials, it is important to understand how trial sponsorship differs among different therapeutic modalities and cancer types and to consider the ramifications of these differences. METHODS We searched clinicaltrials.gov for a cross-sectional register of active, phase III, randomized controlled trials (RCTs) studying treatment-related endpoints such as survival and recurrence for the 24 most prevalent malignancies. We classified the RCTs into 7 categories of therapeutic modality: (1) chemotherapy/other cancer-directed drugs, (2) targeted therapy, (3) surgery, (4) radiation therapy (RT), (5) RT with other modalities, (6) multimodality therapy without RT, and (7) other. RCTs were categorized as being funded by one or more of the following groups: (1) government, (2) hospital/university, (3) industry, and (4) other. χ analysis was performed to detect differences in funding source distribution between modalities and cancer types. RESULTS The percentage of multimodality trials (5%) and radiation RCTs (4%) funded by industry was less than that for chemotherapy (32%, P<0.01) or targeted therapy (48%, P<0.01). Trials studying targeted therapy were less likely to have hospital/university funding than any of the other modalities (P<0.01 in each comparison). Trials of chemotherapy were more likely to be funded by industry if they also studied targeted therapy (P<0.01). CONCLUSION RCTs studying targeted therapies are more likely to be funded by industry than trials studying multimodality therapy or radiation. The impact of industry funding versus institutional or governmental sources of funding for cancer research is unclear and requires further study.
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Fisher CG, Goldschlager T, Boriani S, Varga PP, Rhines LD, Fehlings MG, Luzzati A, Dekutoski MB, Reynolds JJ, Chou D, Berven SH, Williams RP, Quraishi NA, Bettegowda C, Gokaslan ZL. An evidence-based medicine model for rare and often neglected neoplastic conditions. J Neurosurg Spine 2014; 21:704-10. [DOI: 10.3171/2014.7.spine13954] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
Object
The National Institutes of Health recommends strategies to obtain evidence for the treatment of rare conditions such as primary tumors of the spine (PTSs). These tumors have a low incidence and are pathologically heterogeneous, and treatment approaches are diverse. Appropriate evidence-based care is imperative. Failure to follow validated oncological principles may lead to unnecessary mortality and profound morbidity. This paper outlines a scientific model that provides significant evidence guiding the treatment of PTSs.
Methods
A four-stage approach was used: 1) planning: data from large-volume centers were reviewed to provide insight; 2) recruitment: centers were enrolled and provided the necessary infrastructure; 3) retrospective stage: existing medical records were reviewed and completed with survival data; and 4) prospective stage: prospective data collection has been implemented. The AOSpine Knowledge Forum Tumor designed six modules: demographic, clinical, diagnostic, therapeutic, local recurrence, survival, and perioperative morbidity data fields and provided funding.
Results
It took 18 months to implement Stages 1–3, while Stage 4 is ongoing. A total of 1495 tumor cases were captured and diagnosed as one of 18 PTS histotypes. In addition, a PTS biobank network has been created to link clinical data with tumor pathology and molecular analysis.
Conclusions
This scientific model has not only aggregated a large amount of PTS data, but has also established an international collaborative network of spine oncology centers. Access to large volumes of data will generate further research to guide and enhance PTS clinical management. This model could be applied to other rare neoplastic conditions. Clinical trial registration no.: NCT01643174 (ClinicalTrials.gov).
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Affiliation(s)
- Charles G. Fisher
- 1Division of Spine, Department of Orthopaedics, University of British Columbia and Vancouver CoastalHealth, Vancouver, British Columbia
| | - Tony Goldschlager
- 1Division of Spine, Department of Orthopaedics, University of British Columbia and Vancouver CoastalHealth, Vancouver, British Columbia
- 14Monash Institute of Medical Research, Monash University, Clayton, Victoria, Australia; and
| | - Stefano Boriani
- 2Unit of Oncologic and Degenerative Spine Surgery, Rizzoli Institute, Bologna
| | - Peter Paul Varga
- 3National Center for Spinal Disorders and Buda Health Center, Budapest, Hungary
| | - Laurence D. Rhines
- 4Department of Neurosurgery, MD Anderson Cancer Center, The University of Texas, Houston, Texas
| | - Michael G. Fehlings
- 5Division of Neurosurgery, Department of Surgery, University of Toronto and Toronto Western Hospital, Toronto, Ontario, Canada
| | - Alessandro Luzzati
- 6Oncologia Ortopedica e Ricostruttiva del Rachide, Istituto Ortopedico Galeazzi, Milano, Italy
| | | | | | - Dean Chou
- Departments of 9Neurological Surgery and
| | - Sigurd H. Berven
- 10Orthopaedic Surgery, University of California, San Francisco, California
| | - Richard P. Williams
- 11Department of Orthopaedics, Princess Alexandra Hospital, Brisbane, Queensland
| | - Nasir A. Quraishi
- 12Center for Spine Studies and Surgery, Queens Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom;
| | - Chetan Bettegowda
- 13Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Ziya L. Gokaslan
- 13Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland
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de Souza JA, Santana IA, de Castro G, de Lima Lopes G, Tina Shih YC. Economic analyses in squamous cell carcinoma of the head and neck: a review of the literature from a clinical perspective. Int J Radiat Oncol Biol Phys 2014; 89:989-996. [PMID: 25035201 DOI: 10.1016/j.ijrobp.2014.03.040] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2013] [Revised: 02/28/2014] [Accepted: 03/25/2014] [Indexed: 10/25/2022]
Abstract
The purpose of this review was to describe cost-effectiveness and cost analysis studies across treatment modalities for squamous cell carcinoma of the head and neck (SCCHN), while placing their results in context of the current clinical practice. We performed a literature search in PubMed for English-language studies addressing economic analyses of treatment modalities for SCCHN published from January 2000 to March 2013. We also performed an additional search for related studies published by the National Institute for Health and Clinical Excellence in the United Kingdom. Identified articles were classified into 3 clinical approaches (organ preservation, radiation therapy modalities, and chemotherapy regimens) and into 2 types of economic studies (cost analysis and cost-effectiveness/cost-utility studies). All cost estimates were normalized to US dollars, year 2013 values. Our search yielded 23 articles: 13 related to organ preservation approaches, 5 to radiation therapy modalities, and 5 to chemotherapy regimens. In general, studies analyzed different questions and modalities, making it difficult to reach a conclusion. Even when restricted to comparisons of modalities within the same clinical approach, studies often yielded conflicting findings. The heterogeneity across economic studies of SCCHN should be carefully understood in light of the modeling assumptions and limitations of each study and placed in context with relevant settings of clinical practices and study perspectives. Furthermore, the scarcity of comparative effectiveness and quality-of-life data poses unique challenges for conducting economic analyses for a resource-intensive disease, such as SCCHN, that requires a multimodal care. Future research is needed to better understand how to compare the costs and cost-effectiveness of different modalities for SCCHN.
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Affiliation(s)
| | - Iuri A Santana
- Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil
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Smieliauskas F, Chien CR, Shen C, Geynisman DM, Shih YCT. Cost-effectiveness analyses of targeted oral anti-cancer drugs: a systematic review. PHARMACOECONOMICS 2014; 32:651-680. [PMID: 24821281 DOI: 10.1007/s40273-014-0160-z] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/03/2023]
Abstract
BACKGROUND Over the last 15 years, a paradigm shift in oncology has led to the approval of dozens of targeted oral anti-cancer medications (OAMs), which have become the standard of care for certain cancers. While more convenient for patients than infused drugs, the possibility of non-adherence and the frequently high costs of targeted OAMs have proven controversial. OBJECTIVE Our objective was to perform the first comprehensive review of cost-effectiveness analyses (CEAs) of targeted OAMs. METHODS A literature search in PubMed, The Cochrane Library, and the Health Technology Assessment (HTA) reports published by the National Institute for Health Research HTA Programme in the UK was performed, covering articles published in the 5 years prior to 30 September 2013. Our inclusion criteria were peer-reviewed English-language full-text original research articles with a primary focus on CEA related to targeted OAMs. We categorized these articles by treatment setting (i.e. cancer site/type, line of therapy, and treatment and comparator) and synthesized information from the articles into summary tables. RESULTS We identified 41 CEAs covering nine of the 18 targeted OAMs approved by the US FDA as of December 2012. These medications were studied in seven cancers, most often as second-line therapy for advanced-stage patients. In over half of treatment settings where a targeted OAM was compared with treatment that was not a targeted OAM, targeted OAMs were considered cost effective. Limitations in interpreting these findings include the risk of bias due to author conflicts of interest, cross-country variation, and difficulties in generalizing clinical trial evidence to community practice. CONCLUSIONS Several types of cost-effectiveness studies remain under-represented in the literature on targeted OAMs, including those for follow-on indications approved after the initial indication for a drug and for off-label indications, head-to-head comparisons of targeted OAMs with other targeted OAMs and targeted intravenous therapies, and studies that adopt a perspective other than the payer's. Keeping up with the increasing number of approved targeted OAMs will also prove an important challenge for economic evaluation.
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Deficiencies of methods applied in cost effectiveness analysis of hematological malignancies. J Cancer Policy 2014. [DOI: 10.1016/j.jcpo.2014.01.002] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
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Schmitz S, Ang KK, Vermorken J, Haddad R, Suarez C, Wolf GT, Hamoir M, Machiels JP. Targeted therapies for squamous cell carcinoma of the head and neck: current knowledge and future directions. Cancer Treat Rev 2013; 40:390-404. [PMID: 24176789 DOI: 10.1016/j.ctrv.2013.09.007] [Citation(s) in RCA: 52] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/09/2013] [Revised: 08/26/2013] [Accepted: 09/04/2013] [Indexed: 12/19/2022]
Abstract
Despite progress in the therapeutic management of patients with squamous cell carcinoma of the head and neck (SCCHN), the mortality rate of patients presenting with advanced disease remains high. One approach to improve treatment efficacy is to add novel molecular targeted agents to the classical treatment regimens. Monoclonal antibodies targeting the epidermal growth factor receptor (EGFR) have shown clinical benefits in palliative and curative settings. However, only a minority of patients presenting with recurrent or metastatic (R/M) SCCHN have meaningful tumor regression with these agents and virtually all who do develop acquired tumor resistance after a few months of treatment. For these reasons, other inhibitors of EGFR or molecules that interfere with known molecular pathways activated in SCCHN are of considerable interest, either as single agents or in combination with other treatment modalities. In this review, we discuss the different molecular therapeutic approaches explored in SCCHN. We also briefly outline new trial designs that could be used to accelerate the investigation of emerging therapeutic agents in this disease.
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Affiliation(s)
- Sandra Schmitz
- Cancer Center, Department of Medical Oncology and Head and Neck Surgery, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université Catholique de Louvain, Avenue Hippocrate 10, 1200 Brussels, Belgium.
| | - Kie Kian Ang
- Department of Radiation Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.
| | - Jan Vermorken
- Antwerp University Hospital, Department of Medical Oncology, Wilrijkstraat 10, 2650 Edegem, Belgium.
| | - Robert Haddad
- Department of Medical Oncology, Head and Neck Oncology Program, Dana-Farber Cancer Institute, Harvard Medical School, 450 Brookline Avenue, Boston, MA 02215, USA.
| | - Carlos Suarez
- Department of Otolaryngology, Hospital Universitario Central de Asturias Oviedo, Celestino Villamil SN, 33006 Oviedo, Asturias, Spain.
| | - Gregory T Wolf
- Department of Otolaryngology-Head and Neck Surgery, University of Michigan Health System, Ann Arbor, MI 48109, USA.
| | - Marc Hamoir
- Cancer Center, Department of Medical Oncology and Head and Neck Surgery, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université Catholique de Louvain, Avenue Hippocrate 10, 1200 Brussels, Belgium.
| | - Jean-Pascal Machiels
- Cancer Center, Department of Medical Oncology and Head and Neck Surgery, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université Catholique de Louvain, Avenue Hippocrate 10, 1200 Brussels, Belgium.
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Persönlicher – besser – kostengünstiger? Kritische medizinethische Anfragen an die „personalisierte Medizin“. Ethik Med 2013. [DOI: 10.1007/s00481-013-0272-6] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/03/2023]
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Catalá-López F, Sanfélix-Gimeno G, Ridao M, Peiró S. When are statins cost-effective in cardiovascular prevention? A systematic review of sponsorship bias and conclusions in economic evaluations of statins. PLoS One 2013; 8:e69462. [PMID: 23861972 PMCID: PMC3704635 DOI: 10.1371/journal.pone.0069462] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/28/2012] [Accepted: 06/10/2013] [Indexed: 12/03/2022] Open
Abstract
Background We examined sponsorship of published cost-effectiveness analyses of statin use for cardiovascular (CV) prevention, and determined whether the funding source is associated with study conclusions. Methods and Findings We searched PubMed/MEDLINE (up to June 2011) to identify cost-effectiveness analyses of statin use for CV prevention reporting outcomes as incremental costs per quality-adjusted life years (QALY) and/or life years gained (LYG). We examined relationships between the funding source and the study conclusions by means of tests of differences between proportions. Seventy-five studies were included. Forty-eight studies (64.0%) were industry-sponsored. Fifty-two (69.3%) articles compared statins versus non-active alternatives. Secondary CV prevention represented 42.7% of articles, followed by primary CV prevention (38.7%) and both (18.7%). Overall, industry-sponsored studies were much less likely to report unfavourable or neutral conclusions (0% versus 37.1%; p<0.001). For primary CV prevention, the proportion with unfavourable or neutral conclusions was 0% for industry-sponsored studies versus 57.9% for non-sponsored studies (p<0.001). Conversely, no statistically significant differences were identified for studies evaluating secondary CV prevention (0% versus 12.5%; p=0.222). Incremental costs per QALY/LYG estimates reported in industry-sponsored studies were generally more likely to fall below a hypothetical willingness-to-pay threshold of US $50,000. Conclusions Our systematic analysis suggests that pharmaceutical industry sponsored economic evaluations of statins have generally favored the cost-effectiveness profile of their products particularly in primary CV prevention.
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Affiliation(s)
- Ferrán Catalá-López
- Centro Superior de Investigación en Salud Pública (CSISP-FISABIO), Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Valencia, Spain.
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Johnson DH. Financial Disclosure, Industry Sponsorship, and Integrity in Cancer Research Reporting. J Clin Oncol 2013; 31:2243-5. [DOI: 10.1200/jco.2013.48.8817] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
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Soler-Martínez S. On the cost-effectiveness of dabigatran. REVISTA ESPANOLA DE CARDIOLOGIA (ENGLISH ED.) 2013; 66:512. [PMID: 24776063 DOI: 10.1016/j.rec.2012.12.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/23/2012] [Accepted: 12/04/2012] [Indexed: 06/03/2023]
Affiliation(s)
- Santiago Soler-Martínez
- Servicio de Hematología y Hemoterapia, Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas de Gran Canaria, Spain.
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Bariani GM, de Celis Ferrari ACR, Hoff PM, Krzyzanowska MK, Riechelmann RP. Self-reported conflicts of interest of authors, trial sponsorship, and the interpretation of editorials and related phase III trials in oncology. J Clin Oncol 2013; 31:2289-95. [PMID: 23630201 DOI: 10.1200/jco.2012.46.6706] [Citation(s) in RCA: 37] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
PURPOSE Growing participation by industry in cancer research has resulted in increased reporting of conflicts of interest (COI). We aimed to test any association between authors' conclusions and self-reported COI or trial sponsorship in cancer studies. METHODS Editorials and related phase III trials published in six clinical oncology journals in the last 3.5 years were analyzed independently by two investigators who classified study conclusions according to authors' endorsement of the experimental therapy. Logistic regression multivariable models were used to assess predictors of favorable conclusions of editorialists and of phase III authors. RESULTS From January 2008 to October 2011, 1,485 articles were retrieved: 150 phase III trials and 150 editorials were eligible. Among the phase III trials, 82 (54.7%) had positive results, and 78 (52.0%) were entirely or partially funded by industry. Any COI were disclosed in 103 phase III trials (68.7%) and in 71 editorials (47.3%). Multivariable analysis showed that phase III trial results were the only significant predictor for a positive conclusion by trial authors (odds ratio [OR], 92.2; 95% CI, 19.7 to 431.6; P < .001). Sponsorship did not predict for positive conclusion by phase III authors (OR, 0.86; 95% CI, 0.3 to 2.5; P = .788). The only factor associated with positive conclusions by editorial authors was a positive conclusion by phase III trial authors (OR, 36.3; 95% CI, 6.8 to 194.2; P < .001). CONCLUSION The interpretation of recently published phase III cancer trials by their authors or by editorialists was not influenced by financial relationships or industry sponsorship. Increased awareness of COI policies may have led to more integrity in cancer research reporting.
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Tam VC, Ko YJ, Mittmann N, Cheung MC, Kumar K, Hassan S, Chan KKW. Cost-effectiveness of systemic therapies for metastatic pancreatic cancer. ACTA ACUST UNITED AC 2013; 20:e90-e106. [PMID: 23559890 DOI: 10.3747/co.20.1223] [Citation(s) in RCA: 48] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
PURPOSE Gemcitabine and capecitabine (gem-cap), gemcitabine and erlotinib (gem-e), and folfirinox (5-fluorouracil-leucovorin-irinotecan-oxaliplatin) are new treatment options for metastatic pancreatic cancer, but they are also more expensive and potentially more toxic than gemcitabine alone (gem). We conducted a cost-effectiveness analysis of these treatment options compared with gem. METHODS A Markov model was constructed to examine costs and outcomes of gem-cap, gem-e, folfirinox, and gem in patients with metastatic pancreatic cancer from the perspective of a government health care plan. Ontario health economic and costing data (2010 Canadian dollars) were used. Efficacy data for the treatments were obtained from the published literature. Resource utilization data were derived from a chart review of consecutive metastatic patients treated for pancreatic cancer at Princess Margaret Hospital, Toronto, Ontario, 2008-2009, and supplemented with data from the literature. Utilities were obtained by surveying medical oncologists across Canada using the EQ-5D. Incremental cost-effectiveness ratios (icers) were calculated. RESULTS The icers for gem-cap, gem-e, and folfirinox compared with gem were, respectively, CA$84,299, CA$153,631, and CA$133,184 per quality-adjusted life year (qaly). The model was driven mostly by drug acquisition costs. Given a willingness-to-pay (wtp) threshold greater than CA$130,000/qaly, folfirinox was most cost-effective treatment. When the wtp threshold was less than CA$80,000/qaly, gem alone was most cost-effective. The gem-e option was dominated by the other treatments. CONCLUSIONS The most cost-effective treatment for metastatic pancreatic cancer depends on the societal wtp threshold. If the societal wtp threshold were to be relatively high or if drug costs were to be substantially reduced, folfirinox might be cost-effective.
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Affiliation(s)
- V C Tam
- Division of Medical Oncology and Hematology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON. ; Department of Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, AB
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Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs AH, Mauskopf J, Loder E. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2013; 16:231-50. [PMID: 23538175 DOI: 10.1016/j.jval.2013.02.002] [Citation(s) in RCA: 1549] [Impact Index Per Article: 129.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/21/2023]
Abstract
BACKGROUND Economic evaluations of health interventions pose a particular challenge for reporting because substantial information must be conveyed to allow scrutiny of study findings. Despite a growth in published reports, existing reporting guidelines are not widely adopted. There is also a need to consolidate and update existing guidelines and promote their use in a user-friendly manner. A checklist is one way to help authors, editors, and peer reviewers use guidelines to improve reporting. OBJECTIVE The task force's overall goal was to provide recommendations to optimize the reporting of health economic evaluations. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines into one current, useful reporting guidance. The CHEERS Elaboration and Explanation Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force facilitates the use of the CHEERS statement by providing examples and explanations for each recommendation. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. METHODS The need for new reporting guidance was identified by a survey of medical editors. Previously published checklists or guidance documents related to reporting economic evaluations were identified from a systematic review and subsequent survey of task force members. A list of possible items from these efforts was created. A two-round, modified Delphi Panel with representatives from academia, clinical practice, industry, and government, as well as the editorial community, was used to identify a minimum set of items important for reporting from the larger list. RESULTS Out of 44 candidate items, 24 items and accompanying recommendations were developed, with some specific recommendations for single study-based and model-based economic evaluations. The final recommendations are subdivided into six main categories: 1) title and abstract, 2) introduction, 3) methods, 4) results, 5) discussion, and 6) other. The recommendations are contained in the CHEERS statement, a user-friendly 24-item checklist. The task force report provides explanation and elaboration, as well as an example for each recommendation. The ISPOR CHEERS statement is available online via Value in Health or the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices - CHEERS Task Force webpage (http://www.ispor.org/TaskForces/EconomicPubGuidelines.asp). CONCLUSIONS We hope that the ISPOR CHEERS statement and the accompanying task force report guidance will lead to more consistent and transparent reporting, and ultimately, better health decisions. To facilitate wider dissemination and uptake of this guidance, we are copublishing the CHEERS statement across 10 health economics and medical journals. We encourage other journals and groups to consider endorsing the CHEERS statement. The author team plans to review the checklist for an update in 5 years.
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Affiliation(s)
- Don Husereau
- Institute of Health Economics, Edmonton, Canada.
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Conter HJ. Role of Financial Relationships in Economic Analyses of Targeted Therapies in Oncology Remains Unclear. J Clin Oncol 2012; 30:3895; author reply 3895. [DOI: 10.1200/jco.2012.43.4605] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
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Valachis A, Polyzos NP, Nearchou A, Lind P, Mauri D. Reply to H.J. Conter. J Clin Oncol 2012. [DOI: 10.1200/jco.2012.44.6906] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Affiliation(s)
| | - Nikolaos P. Polyzos
- Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium
| | | | - Pehr Lind
- Mälarsjukhuset, Eskilstuna; and Karolinska Institutet, Stockholm, Sweden
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Kerr D, Elzawawy A. Manufacturer sponsorship bias in economic analyses matters. Nat Rev Clin Oncol 2012; 9:309-10. [DOI: 10.1038/nrclinonc.2012.75] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
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