04-Aug-2016
The International Consortium of Investigators for Fairness in Trial Data Sharing have published a response to the The International Committee of Medical Journal Editors (ICMJE) proposed plan for sharing data from randomized, controlled trials (RCTs). This plan will require, as a condition of acceptance of trial results for publication, that authors make publicly available the deidentified individual patient data underlying the analyses reported in an article. The response recommends that the ICMJE come together with trialists and other stakeholders to discuss the potential benefits, risks, burdens, and opportunity costs of its proposal and explore alternatives that will achieve the same goals efficiently.