A New Era in Transparency in Clinical Trial Data

The open science movement is gaining momentum, with a particular emphasis on the sharing of deidentified, individual-patient, clinical trial data. However, to date there have been relatively few incentives to share and fewer consequences of not sharing. That circumstance is about to change.

The International Committee of Medical Journal Editors (ICMJE) is now using its considerable influence to rectify the reluctance of many trialists to share data. The Committee has proposed to require authors of clinical trial reports to share data at the deidentified individual-patient level that underlie the article's results, as well as the associated metadata, within 6 months of publication. The Committee also proposes that the trialists document their…