Abstract
BackgroundIndividual participant data (IPD) from completed clinical trials should be responsibly shared to support efficient clinical research, generate new knowledge and bring benefit to patients. The Medical Research Council (MRC) Hubs for Trials Methodology Research (HTMR) has developed guidance to facilitate the sharing of IPD from publicly funded clinical trials.MethodsDevelopment of the guidance was completed over four phases which included a focussed review of policy documents, a web-based survey of the UK Clinical Research Collaboration (CRC) Registered Clinical Trials Units (CTU) Network, participation of an expert committee and an open consultation with the UKCRC Registered CTU Network. The project was funded by the MRC HTMR (MR/L004933/1-R39).ResultsGood practice principles include: (i) the use of a controlled access approach, using a transparent and robust system to review requests and provide secure data access; (ii) seeking consent for sharing IPD from trial participants in all future clinical trials with adequate assurance that patient privacy and confidentiality can be maintained; and (iii) establishing an approach to resource the sharing of IPD which would include support from trial funders, sponsor organisations and users of IPD. The guidance has been endorsed by Cancer Research UK, MRC Methodology Research Programme Advisory Group, Wellcome Trust and the Executive Group of the UKCRC Registered CTU Network. The National Institute for Health Research (NIHR) has confirmed it is supportive of the application of this guidance.ConclusionsImplementation of these principles will improve transparency, increase the coherent sharing of IPD from publicly funded trials, and help publicly funded trials to adhere to trial funder and journal requirements for data sharing.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-015-0532-z) contains supplementary material, which is available to authorized users.
Highlights
Individual participant data (IPD) from completed clinical trials should be responsibly shared to support efficient clinical research, generate new knowledge and bring benefit to patients
In this article we summarise the process used to develop a guidance document for publicly funded clinical trials and outline the key principles of good practice that aim to increase and improve the uptake of responsible data sharing in this key stakeholder group
Development of the guidance was funded by the Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (HTMR)
Summary
Individual participant data (IPD) from completed clinical trials should be responsibly shared to support efficient clinical research, generate new knowledge and bring benefit to patients. Before a clinical trial begins recruiting participants the trial should be ‘registered’ in a clinical trials registry such as ClinicalTrials.gov. This public record of completed and ongoing trials assures transparency and reduces the potential for publication bias, which is known to be a significant problem in medical research [1]. The summary results should be fully reported and published in medical journals [2] and trial registries, but utility of the IPD continues as they provide enormous potential to investigate further clinical and/or methodological questions beyond those that the trial had been originally designed to. Several clinical trial funders and journals require that the IPD from a clinical trial is made available on reasonable request [3,4,5,6] after completion of the trial
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