June 27, 2017, Vol 317, No. 24, Pages 2463-2560
Data Sharing Statements for Clinical Trials A Requirement of the International Committee of Medical Journal Editors
Darren B. Taichman, MD, PhD; Peush Sahni, MB, BS, MS, PhD; Anja Pinborg, MD; et al.
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 deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups.1 Some applauded the proposal while others expressed disappointment it did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers…