Evaluating adherence to the International Committee of Medical Journal Editors’ policy of mandatory, timely clinical trial registration

Objective: To determine whether two specific criteria in Uniform Requirements for Manuscripts (URM) created by International Committee of Medical Journal Editors (ICMJE) of including the trial ID registration within manuscripts and timely registration of trials are being followed. Materials and Methods: Observational study using computerized analysis of publicly available MEDLINE article data and clinical trial registry data. We analyzed a purposive set of five ICMJE founding journals looking at all trial articles published in those journals during 2010-2011, and data from the ClinicalTrials.gov trial registry. We measured adherence to trial ID inclusion policy as the percentage of trial journal articles that contained a valid trial ID within the article (journal-based sample). Adherence to timely registration was measured as percentage of trials that registered the trial prior enrolling the first participant within a 60-day grace period. We also examined timely registration rates by ye...