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Journal editors tighten publication conditions 

The International Committee of Medical Journal Editors (ICMJE) issued a statement that the 11 member journals will require, as a condition of consideration for publication, registration in a public trials registry for clinical studies involving human patients. 

The editorial outlining the new policy was published online simultaneously by all ICMJE member journals and is posted on the JAMA Web site, http://www.JAMA.com. It will also appear in print in the Sept. 15 issue of JAMA.

“Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor’s product,” the journal states. “Unfortunately, selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision making.” 

The ICMJE editors wrote that the trials must register at or before the onset of patient enrollment and that this policy applies to any clinical trial starting enrollment after July 1, 2005.  “We speak only for ourselves, but we encourage editors of other biomedical journals to adopt similar policies  …  The ICMJE does not advocate one particular registry, but its member journals will require authors to register their trial in a registry that meets several criteria. The registry must be accessible to the public at no charge.  It must be open to all prospective registrants and managed by a not-for-profit organization.  There must be a mechanism to ensure the validity of the registration data, and the registry should be electronically searchable.” 

The editors listed the further details they will require in a public registry in this editorial and note that at present, only http://www.clinicaltrials.gov, sponsored by the United States National Library of Medicine, meets the requirements.

“Registration is only part of the means to an end; that end is full transparency with respect to performance and reporting of clinical trials …  Patients who volunteer to participate in clinical trials deserve to know that their contribution to improving human health will be available to inform health care decisions. The knowledge made possible by their collective altruism must be accessible to everyone. Required trial registration will advance this goal.”

Friday, Sept. 10, 2004
Catalyst Online is published weekly, updated as needed and improved from time to time by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to petersnd@musc.edu or catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Community Press at 849-1778.