Data from: 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 year of all
phase II and higher interventional trials in ClinicalTrials.gov
(registry-based sample). Results: To determine trial ID inclusion, we
analyzed 698 clinical trial articles in five journals. A total of 95.8% of
trial journal articles included the trial ID. In 88.3% the trial-article
link is stored within a structured MEDLINE field. To evaluate timely
registration, we analyzed trials referenced by 451 articles from the
selected five journals. A total of 60% of articles were registered in a
timely manner with an improving trend for trials initiated in later years
(e.g., 89% of trials that initiated in 2008 were registered in a timely
manner). In the registry-based sample, the timely registration rates
ranged from 56% for trials registered in 2006 to 72% for trials registered
in 2011. Discussion: Adherence to URM requirements for registration and
trial ID inclusion increases the utility of PubMed and links it in an
important way to clinical trial repositories. This new integrated
knowledge source can facilitate research prioritization, clinical
guidelines creation and precision medicine. Conclusions: The five selected
journals adhere well to the policy of mandatory trial registration and
also outperform the registry in adherence to timely registration. ICMJE’s
URM policy represents a unique international mandate that may be providing
a powerful incentive for sponsors and investigators to document clinical
trials and trial result publications and thus fulfill important
obligations to trial participants and society.