Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors

The Lancet
Jun 10, 2017 Volume 389 Number 10086 p2263-2348  e12-e14
http://www.thelancet.com/journals/lancet/issue/current

Comment
Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors
Darren B Taichman, Peush Sahni, Anja Pinborg, Larry Peiperl, Christine Laine, Astrid James, Sung-Tae Hong, Abraham Haileamlak, Laragh Gollogly, Fiona Godlee, Frank A Frizelle, Fernando Florenzano, Jeffrey M Drazen, Howard Bauchner, Christopher Baethge, Joyce Backus
Summary
The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January, 2016, we published a proposal aimed at helping to create an environment in which the sharing of de-identified individual participant data becomes the norm.1 In response to our request for feedback we received many comments from individuals and groups. Some applauded the proposals, while others expressed disappointment they did not more quickly create a commitment to data sharing.