Endorsement and implementation of high impact factor medical journals on the International Committee of Medical Journal Editors (ICMJE) policy of mandatory clinical trial registration

Wasee Tulvatana 1 , 2 , Bandit Thinkhamrop 1 , 3 , Kittisak Kulvichit 1 , 4 ,  and Pyatat Tatsanavivat 1 , 5
  • 1 Thai Clinical Trials Registry, The Medical Research Foundation, Nonthaburi 11000, Thailand Thailand
  • 2 Correspondence to: MD, MSc, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University, Thailand
  • 3 Department of Biostatistics and Demography, Faculty of Public Health, Thailand
  • 4 Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University, Thailand
  • 5 Department of Internal Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand


Objective: We determined the proportion of highest impact factor journals that follows the ICMJE policy of clinical trial registration and identified factors associated with policy implementation.

Study design and setting: Ten highest impact factor journals from ten specialties were identified from the 2009 Journal Citation Reports. Instructions for authors were reviewed for the statements regarding the trial registration. If the registration policy was mentioned in the instructions, the published articles were assessed to determine if the policy was actually implemented. The publishers, membership in Committee on Publication Ethics, journal vintage, etc., were analyzed for association with the policy implementation.

Results: Of 87 relevant journals, 58.6% endorsed the policy and 35.6% strictly implemented it. Factors for journals associated with strict clinical trial registration policy implementation were Internal Medicine specialty (OR 19.19; 95%CI: 2.21, 166.50; p = 0.007), ICMJE’s URM followers (OR 7.14; 95%CI: 2.62, 19.46; p <0.001), longer years of publication (OR for every 10 year 1.31; 95%CI: 1.16, 1.49; p = 0.001), and higher impact factors (OR for every 1 JIF 1.70; 95%CI: 1.25, 2.32; p = 0.001).

Conclusion: Only one third of the highest impact factor journals strictly implemented ICMJE policy. Associated factors were identified.

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  • 1. Tulvatana W, Thinkhamrop B, Kulvichit K, Tatsanavivat P. Thai Clinical Trials Registry. J Evid Based Med. 2011; 4:182-4.

  • 2. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004; 351: 1250-1.

  • 3. World Health Organizaion. International Clinical Trials Registry Platform (ICTRP): What is a clinical trial? Available at: http://www.who.int/ictrp/en/. Accessed May 3, 2011.

  • 4. World Health Organizaion. International Clinical Trials Registry Platform Search Portal. Available at: http://apps.who.int/trialsearch/. Accessed May 3, 2011.

  • 5. International Committee of Medical Journal Editors. Journals that have Requested Inclusion on the List of Publications that follow the ICMJE’s Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Available at: http://www.icmje.org/journals.html. Accessed May 3, 2011.

  • 6. Committee on Publication Ethics. Members. Available at http://publicationethics.org/members. Accessed May 3, 2011.

  • 7. Kulvichit K, Kulwichit W, Lumbiganon P. Clinical trial registration. N Engl J Med. 2005; 352:198-9.

  • 8. Reveiz L, Cortes-Jofre M, Asenjo Lobos C, Nicita G, Ciapponi A, Garcia-Dieguez M, et al. Influence of trial registration on reporting quality of randomized trials: Study from highest ranked journals. J Clin Epidemiol. 2010; 63:1216-22.

  • 9. Hopewell S, Altman DG, Moher D, Schulz KF. Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal ‘Instructions to Authors’. Trials. 2008; 9:20.

  • 10. World Medical Association. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Available at: http://www.wma.net/en/30publications/10policies/b3/index.html. Accessed November 23, 2011.


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