• J Clin Epidemiol · Feb 2016

    UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns.

    • Carolyn Hopkins, Matthew Sydes, Gordon Murray, Kerry Woolfall, Mike Clarke, Paula Williamson, and Catrin Tudur Smith.
    • MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
    • J Clin Epidemiol. 2016 Feb 1; 70: 17-25.

    ObjectivesEvaluate current data sharing activities of UK publicly funded Clinical Trial Units (CTUs) and identify good practices and barriers.Study Design And SettingWeb-based survey of Directors of 45 UK Clinical Research Collaboration (UKCRC)-registered CTUs.ResultsTwenty-three (51%) CTUs responded: Five (22%) of these had an established data sharing policy and eight (35%) specifically requested consent to use patient data beyond the scope of the original trial. Fifteen (65%) CTUs had received requests for data, and seven (30%) had made external requests for data in the previous 12 months. CTUs supported the need for increased data sharing activities although concerns were raised about patient identification, misuse of data, and financial burden. Custodianship of clinical trial data and requirements for a CTU to align its policy to their parent institutes were also raised. No CTUs supported the use of an open access model for data sharing.ConclusionThere is support within the publicly funded UKCRC-registered CTUs for data sharing, but many perceived barriers remain. CTUs are currently using a variety of approaches and procedures for sharing data. This survey has informed further work, including development of guidance for publicly funded CTUs, to promote good practice and facilitate data sharing.Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

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