Clinical Trials Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
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.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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
Abstract
AIM

To develop a survey to help define the main problems in radiological clinical trials.

METHODS

Since 2006, we have managed seven different radiological clinical trials recruiting patients in academic and non-academic centres. We developed a preliminary questionnaire using a four-round Delphi approach to identify problems occurring in radiological clinical trials run at our centre. We investigated the recruitment experience, involvement of all multi-disciplinary team members and main obstacles to completing the projects. A final round of Delphi processes elucidated solutions to the identified problems.

RESULTS

Among 19/20 (95%) respondents, 10 (53%) were young physicians (under 35 years old), and the respondents included non-faculty members, fellows, residents, and undergraduate students. Ninety-four percent (18/19) of respondents showed interest in conducting clinical trials. On a scale of 1 to 10, the problems with higher/worse scores (8-9) were related to technical or communication problems. The most frequent problems across all studies were technical problems related to clinical trial equipment, insufficient willingness to participate, obstacles to understanding the design of electronic-case report form and extra work.

CONCLUSION

The developed questionnaire identified the main recurring problems in radiological clinical trials as perceived by end-users and helped define possible solutions that are mostly related to having dedicated clinical trial research staff.

Keywords: Clinical trials; Data management; Magnetic resonance imaging; Mammography; Ultrasonography

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.