Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors

Abstract

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world-foundations, government agencies, and industry-now mandate data sharing. Here we outline ICMJE's proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone can provide feedback at www.icmje.org by 18 April 2016.The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Further details may be found in the "Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals" at www.icmje.org.As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individualpatient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. The data underlying the results are defined as the IPD required to reproduce the article's findings, including necessary metadata. This requirement will go into effect for clinical trials that begin to enroll participants beginning 1 year after the ICMJE adopts its data-sharing requirements. † Enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used. By changing the requirements of the manuscripts we will consider for publication in our journals, editors can help foster this endeavor. As editors, our direct influence is logically, and practically, limited to those data underpinning the results and analyses we publish in our journals.

Research Techniques Made Simple: Workflow for Searching Databases to Reduce Evidence Selection Bias in Systematic Reviews

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“…As highlighted in related Research Techniques Made Simple articles, reporting bias remains one of the greatest threats to the validity of systematic reviews (2016;Abuabara et al, 2012).…”

Meta-analysis of aggregate data on medical events

“…from RCTs (Bertagnolli et al, 2017;Strom et al, 2014;Taichman et al, 2016), methods for AD are important for a number of reasons. Firstly, it is uncertain whether IPD will ever be accessible for historic clinical trials, to which new journal requirements or voluntary disclosure commitments do not apply.…”

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