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Sharing data from clinical trials: the rationale for a controlled access approach.

Sydes, MR; Johnson, AL; Meredith, SK; Rauchenberger, M; South, A; Parmar, MK; (2015) Sharing data from clinical trials: the rationale for a controlled access approach. Trials , 16 (1) , Article 104. 10.1186/s13063-015-0604-6. Green open access

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Abstract

The move towards increased transparency around clinical trials is welcome. Much focus has been on under-reporting of trials and access to individual patient data to allow independent verification of findings. There are many other good reasons for data sharing from clinical trials. We describe some key issues in data sharing, including the challenges of open access to data. These include issues in consent and disclosure; risks in identification, including self-identification; risks in distorting data to prevent self-identification; and risks in analysis. These risks have led us to develop a controlled access policy, which safeguards the rights of patients entered in our trials, guards the intellectual property rights of the original researchers who designed the trial and collected the data, provides a barrier against unnecessary duplication, and ensures that researchers have the necessary resources and skills to analyse the data.

Type: Article
Title: Sharing data from clinical trials: the rationale for a controlled access approach.
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1186/s13063-015-0604-6
Publisher version: http://dx.doi.org/10.1186/s13063-015-0604-6
Language: English
Additional information: © 2015 Sydes et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/1465586
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