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Forcing Pharma's Hand


By Catherine Varmazis

August 8, 2007 | Two years ago, the International Committee of Medical Journal Editors (ICMJE) threw down the gauntlet before clinical investigators. In response to criticism over big pharma’s hesitancy to register ongoing clinical trials, the 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.

In a May editorial in the NEJM, the ICMJE looked back with satisfaction at the “overwhelming” response to its watershed 2005 initiative. “The research community has embraced trial registration,” the article states, citing the growing 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 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 had previously been 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.”

The ICMJE recognizes the growing call for registration not only of trial methods, but also trial results. For now, the ICMJE will not consider an abstract of trial results 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.”

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