"Data Sharing Statements for Clinical Trials—A Requirement of the International Committee of Medical Journal Editors"

Darren B. Taichman et al. have published "Data Sharing Statements for Clinical Trials—A Requirement of the International Committee of Medical Journal Editors" in PLOS Medicine.

Here's an excerpt:

Therefore, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in our member journals:

  1. As of July 1, 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below.
  2. Clinical trials that begin enrolling participants on or after January 1, 2019 must include a data sharing plan in the trial’s registration. The ICMJE's policy regarding trial registration is explained at www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.

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Author: Charles W. Bailey, Jr.

Charles W. Bailey, Jr.