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AOA Communication  |   November 2006
JAOA Now Requires Public Registration of Clinical Trials
Author Affiliations
  • Audrey K. Daniel, BA
    Ms Daniel is the editorial assistant for JAOA—The Journal of the American Osteopathic Association.
Article Information
AOA Communication   |   November 2006
JAOA Now Requires Public Registration of Clinical Trials
The Journal of the American Osteopathic Association, November 2006, Vol. 106, 638. doi:10.7556/jaoa.2006.106.11.638
The Journal of the American Osteopathic Association, November 2006, Vol. 106, 638. doi:10.7556/jaoa.2006.106.11.638
JAOA—The Journal of the American Osteopathic Association has joined the member journals of the International Committee of Medical Journal Editors (ICMJE)1 in insisting that all phase 3 clinical trials be registered with at least one public registry. In addition, the JAOA is requiring that all other trials involving human subjects, including pilot studies, be registered if they have one prospectively assigned concurrent control or comparison group. 
To be considered for publication in the JAOA, all qualifying trials that begin on or after December 1, 2006, must be publicly registered before the trials begin. Researchers who submit manuscripts to the JAOA between September 1, 2006, and December 1, 2006, have until December 1, 2006, to register their trials. Manuscripts that were submitted to the JAOA before September 1, 2006, are exempt from this requirement. 
The JAOA agrees with the ICMJE's requirements for an acceptable public registry: “The registry must be electronically searchable and accessible to the public at no charge. It must be open to all registrants and be not for profit. It must have a mechanism to ensure the validity of the registration data.”1 ClinicalTrials.gov, which is sponsored by the National Library of Medicine, is the most prominent registry in the United States that meets these requirements. 
In registering trials, researchers must provide the 20 pieces of data that the World Health Organization identified in 2005 as essential for informing the public.2 These required items include the unique trial number, trial registration date, funding sources, primary and secondary sponsors, interventions, and outcomes (Figure). For more information, visit http://www.icmje.org/clin_trialup.htm or http://www.who.int/ictrp/data_set/en/index1.html. 
Figure.
A list of the required items for public registration of clinical trials. The 20 data fields shown were specified at a meeting convened by the World Health Organization in April 2004. 1
Figure.
A list of the required items for public registration of clinical trials. The 20 data fields shown were specified at a meeting convened by the World Health Organization in April 2004. 1
See the JAOA's “Information for Contributors” on page 624 of this issue or http://www.jaoa.org/misc/ifora.shtml for additional information concerning clinical trial registration and other aspects of manuscript submission. Journal contributors can also contact JAOA Editorial Assistant Audrey K. Daniel by calling (800) 621-1773, extension 8166; by sending e-mail to adaniel@osteopathic.org; by faxing messages to (312) 202-8466; or by writing to JAOA—The Journal of the American Osteopathic Association, 142 E Ontario St, Chicago, IL 60611-2864. 
 This article was first published in the October 2006 issue of the JAOA and will be republished periodically in the JAOA and other AOA publications.
 
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 [International Committee of Medical Journal Editors Web site]. May 2005. Available at: http://www.icmje.org/clin_trialup.htm. Accessed September 15, 2006.
International Clinical Trials Registry Platform. Registration data set. World Health Organization Web site. May 16, 2006. Available at: http://www.who.int/ictrp/data_set/en/index1.html. Accessed September 15, 2006.
Figure.
A list of the required items for public registration of clinical trials. The 20 data fields shown were specified at a meeting convened by the World Health Organization in April 2004. 1
Figure.
A list of the required items for public registration of clinical trials. The 20 data fields shown were specified at a meeting convened by the World Health Organization in April 2004. 1