Medical Journals Repeat Drug Trial Rules

In a joint editorial, the editors of eleven international medical journals have repeated their requirement that clinical drug trials that begin enrollment on or after July 1, 2005, be registered in a public registry that is electronically searchable and publicly accessible at no charge before the first patient is enrolled.

The journals have announced they will accept retrospective registration of trials that began enrollment before July 2005 as long as registration is complete by September 13, 2005. This announcement amplifies the requirement stated in an editorial in September 2004 by the International Committee of Medical Journal Editors (ICMJE).

"Our first editorial was a wake-up call for researchers, trial authors, and sponsors,” noted Harold Sox, editor of Annals of Internal Medicine. "This editorial reaffirms our intent and tells researchers what they must do to meet our requirements for editorial review and subsequent publication.”

The ICMJE states that researchers must not omit key information when they register a trial. Specifically, they must name the treatment in a meaningful way so that patients and others know what intervention is under study. Authors are advised not to "use meaningless phrases to describe key information.” The ICMJE has adopted the minimal data set of the World Health Organization (WHO, Geneva, Switzerland), a list of required items that must be included in every trial.

The editorial was released on the ICMJE website (www.icmje.org) on May 23, 2005. Participating journals include The New England Journal of Medicine, Norwegian Medical Journal, The Lancet, The Journal of the American Medical Association, Journal of the Danish Medical Association, Croatian Medical Journal, the New Zealand Medical Journal, the Canadian Medical Association Journal, the Dutch Journal of Medicine, the Medical Journal of Australia, and the Annals of Internal Medicine.




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