Valdora F, Bignotti B, Calabrese M, Houssami N, Tagliafico A. Radiological clinical trials: Proposal of a problem-finding questionnaire to improve study success. World J Methodol 2016; 6(4): 214-219 [PMID: 28074173 DOI: 10.5662/wjm.v6.i4.214]
Corresponding Author of This Article
Alberto Tagliafico, MD, Assistant Professor of Human Anatomy, Department of Experimental Medicine (DIMES) - Institute of Anatomy, University of Genoa, Via De Toni 14, 16132 Genoa, Italy. albertotagliafico@gmail.com
Research Domain of This Article
Methodology
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Clinical Trials Study
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Dec 26, 2016 (publication date) through Feb 14, 2026
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Publication Name
World Journal of Methodology
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2222-0682
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Valdora F, Bignotti B, Calabrese M, Houssami N, Tagliafico A. Radiological clinical trials: Proposal of a problem-finding questionnaire to improve study success. World J Methodol 2016; 6(4): 214-219 [PMID: 28074173 DOI: 10.5662/wjm.v6.i4.214]
World J Methodol. Dec 26, 2016; 6(4): 214-219 Published online Dec 26, 2016. doi: 10.5662/wjm.v6.i4.214
Radiological clinical trials: Proposal of a problem-finding questionnaire to improve study success
Francesca Valdora, Bianca Bignotti, Massimo Calabrese, Nehmat Houssami, Alberto Tagliafico
Francesca Valdora, Alberto Tagliafico, Department of Experimental Medicine (DIMES) - Institute of Anatomy, University of Genoa, 16132 Genoa, Italy
Bianca Bignotti, Department of Health Sciences (DISSAL), University of Genoa, 16132 Genoa, Italy
Massimo Calabrese, Department of Radiology, UOC Senologia Diagnostica, IRCCS AOU San Martino - IST, 16132 Genoa, Italy
Nehmat Houssami, School of Public Health, Sydney Medical School, University of Sydney, Sydney, NSW 2006, Australia
Author contributions: Valdora F, Calabrese M and Tagliafico A designed the study; Valdora F and Bignotti B acquired and analysed the data; Valdora F wrote the paper; Calabrese M, Houssami N and Tagliafico A critically revised the manuscript; Calabrese M and Tagliafico A obtained funding; all authors read and approved the final manuscript.
Institutional review board statement: All studies included in this work were already approved by the respective Ethical Committee.
Clinical trial registration statement: The ASTOUND study is registered at https://clinicaltrials.gov/ct2/show/NCT02066142, and the registration identification number is NCT02066142; the TAM01 study is registered at https://clinicaltrials.gov/ct2/show/NCT01357772?term=tam01&rank=1, and the registration identification number is NCT01357772.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: None declared.
Data sharing statement: No additional data are available.
Correspondence to: Alberto Tagliafico, MD, Assistant Professor of Human Anatomy, Department of Experimental Medicine (DIMES) - Institute of Anatomy, University of Genoa, Via De Toni 14, 16132 Genoa, Italy. albertotagliafico@gmail.com
Telephone: +39-010-3537882 Fax: +39-010-3537885
Received: May 30, 2016 Peer-review started: June 2, 2016 First decision: July 5, 2016 Revised: November 28, 2016 Accepted: December 1, 2016 Article in press: December 1, 2016 Published online: December 26, 2016 Processing time: 204 Days and 16.6 Hours
Core Tip
Core tip: Clinical data management (CDM) is important for efficiently managing and completing a clinical trial. CDM is the process of controlling, processing, validating and querying data generated in a clinical study. In this paper, we developed a questionnaire identifying the main recurring obstacles in radiological clinical trials as perceived by end-users. We tried to define possible solutions that are mostly related to having dedicated clinical trial research staff. This topic is relatively well-known by clinicians, while it is less well-known by radiologists and could be useful for radiological centres that are currently involved or will be involved in conducting or participating in radiological clinical trials. For this reason, we suggested a problem-solving questionnaire and reported our experience in managing seven multi-centre national and international radiological clinical trials.
