Two years ago, the International Committee of Medical Journal Editors (ICMJE) threw down the gauntlet before clinical investigators. In response to widespread criticism over the willingness of big pharma to register ongoing clinical trials, the powerful committee announced that its member journals – including the
New England Journal of Medicine (NEJM), the
Lancet, and the
Journal of the American Medical Association -- would review for publication only those studies that had deposited information about their trial design into an approved clinical trial registry
before enrolling patients.
This week the ICMJE, in an editorial in the NEJM, looked back with apparent satisfaction at the “overwhelming” response to its watershed 2005 initiative. “The research community has embraced trial registration,” states the NEJM editorial, citing the more than tripling of the number of trials in the ClinicalTrials.gov registry – from 13,154 before the ICMJE announced its policy, to over 40,000 today. (For an interview with ClinicalTrial.gov’s Deborah Zarin, see Is That a Target on Her Back? Bio-IT World, March 2005).
Just five registries initially met the ICMJE’s criteria, but today many more “investigators, sponsors, and government agencies” are requesting recognition for their databases. In response to this trend, the ICMJE announced in its editorial that it will accept trial registration in any of the “primary registers” that participate in the International Clinical Trial Registry Platform (ICTRP), developed by the World Health Organization (WHO). These primary registers are “WHO-selected registers managed by not-for-profit entities that will accept registrations for any interventional trials, delete duplicate entries from their own register, and provide data directly to the WHO.”
A second tier of WHO-designated “partner registers” does not meet the ICMJE’s criteria, as some of those registers are managed by for-profit entities.
Further updating its policy, the ICMJE said it was expanding its definition of the types of trials that must be registered: It will now require registration of some kinds of preliminary trials that it had previously excluded. Tacitly acknowledging that its revised guidelines could cause some confusion, the committee encourages those who are uncertain to “err on the side of registration if they wish to seek publication in an ICMJE journal.”
Looking ahead, the ICMJE recognizes the growing call for registration not only of trial methods, but also of trial results. For now, the ICMJE will not consider an abstract of trial results of less than 500 words to be “previous publication,” but cautions that “the editors may consider more detailed deposition of trial results in publicly available registries to be prior publication.”
Related story:
Debating Clinical Registries and Databases, Bio-IT World, April 2006
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