Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors
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20-01-2016
Darren B. Taichman, Joyce Backus, Christopher Baethge, Howard Bauchner, Peter W. de Leeuw, Jeffrey M. Drazen, John Fletcher, Frank A. Frizelle, Trish Groves, Abraham Haileamlak, Astrid James, Christine Laine, Larry Peiperl, Anja Pinborg, Peush Sahni en Sinan Wu

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 the 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 ...