Journal editors demand clinical trial registration

Calling for "transparency with respect to performance and reporting of clinical trials," the editors of a dozen prestigious medical journals have released a joint statement demanding the registration of all clinical trials from July 1, 2005.

The statement, due to be published next week in the New England Journal of Medicine and simultaneously in other prominent medical journals, is signed by 13 members of the International Committee of Medical Journal Editors (ICMJE).

"Altruism and trust lie at the heart of research on human subjects," the statement starts. "Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor's product."

The editors acknowledge that they are less inclined to publish trial results that are negative or inconclusive, but argue that full disclosure of all trials is necessary to "influence the thinking of patients, clinicians, other researchers, and experts who write practice guidelines or decide on insurance-coverage policy."

The ICMJE therefore "proposes comprehensive trials registration as a solution to the problem of selective awareness." To be considered for publication in any of the ICMJE member journals, any trial that begins enrollment after July 1, 2005, must be registered in advance. (Trials that begin before that date must be registered by September 13, 2005.)

Registration could take place in principle at any publicly accessible, non-profit site, although the ICMJE editors believe that only one site - - run by the National Library of Medicine - currently fulfills its criteria.

Among the signatories of the joint statement are Jeffrey Drazen, Editor-in-Chief of the New England Journal of Medicine; Richard Horton, Editor of the Lancet; Catherine De Angelis, Editor-in-Chief of the Journal of the American Medical Association, as well as journal editors from Australia, Croatia, Denmark, the Netherlands, New Zealand, and Norway.

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