title: Evaluating adherence to the International Committee of Medical Journal Editors' policy of mandatory, timely clinical trial registration.
abstract: OBJECTIVE
  To determine whether two specific criteria in Uniform Requirements for Manuscripts (URM) created by the International Committee of Medical Journal Editors (ICMJE)--namely, including the trial ID registration within manuscripts and timely registration of trials, are being followed.
  
  
  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 (CTG) 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 the percentage of trials that registered the trial before 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 CTG (registry-based sample).
  
  
  RESULTS
  To determine trial ID inclusion, we analyzed 698 clinical trial articles in five journals. A total of 95.8% (661/690) 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% (272/451) of articles were registered in a timely manner with an improving trend for trials initiated in later years (eg, 89% of trials that began 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.
  
  
  CONCLUSIONS
  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.
authors: Laboratory for Informatics Development, National Library of Medicine, NIH Clinical Center, Bethesda, Maryland 20892, USA. vojtech.huser@nih.gov
authors: Vojtech
authors: V
authors: Huser
authors: James J
authors: JJ
authors: Cimino
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D016208:Databases, Factual; D035081:Editorial Policies; D046650:Medical Subject Headings; D010506:Periodicals as Topic / Q000592:standards*; D012042:Registries
keywords: Databases; clinical trials as topic/legislation; cross-sectional analysis; publication policy; registries; trial registration
references: PLoS One. 2011;6(9):e25258
references: 21957485
references: N Engl J Med. 2011 Mar 3;364(9):852-60
references: 21366476
references: JAMA. 2009 Sep 2;302(9):977-84
references: 19724045
references: JAMA. 2012 May 2;307(17):1861-4
references: 22550202
references: BMJ. 2010 Mar 23;340:c869
references: 20332511
references: N Engl J Med. 2005 Jun 9;352(23):2436-8
references: 15911780
references: Chest. 2009 Jul;136(1):304-305
references: 19584213
references: Cochrane Database Syst Rev. 2011 Jan 19;(1):MR000031
references: 21249714
references: PLoS One. 2011 Feb 24;6(2):e14701
references: 21383991
references: AMIA Annu Symp Proc. 2012;2012:400-8
references: 23304310
references: JAMA. 2012 May 2;307(17):1838-47
references: 22550198
references: Croat Med J. 2008 Oct;49(5):582-5
references: 18925691