JAOA • Vol 107 • No 1 • January 2007 • 4-
SPECIAL COMMUNICATION (REPRINT) |
JAOA Now Requires Public Registration of Clinical Trials
Audrey K. Daniel, BA
Ms Daniel is the editorial assistant for JAOA—The Journal of
the American Osteopathic Association.
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.
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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
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See the JAOA's "Information for Contributors" on
pages 39-41 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{at}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.
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Footnotes
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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.
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References
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1. 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, 2006.2. 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.
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