Registered Drug Trials

The editors of eleven major medical journals have repeated their call to have clinical drug trials added to a public registry.

In a joint editorial, the members of the International Committee of Medical Journal Editors (ICMJE), said they will consider publishing results of clinical trials that begin enrolment on or after July 1, 2005, only if the trial has been entered in a registry that is electronically searchable and publicly accessible at no charge before the first patient is enrolled. The journals will accept retrospective registration of trials that began enrollment before July 2005 as long as registration is complete by Sept. 13, 2005.

The editorial, “Is This Trial Fully Registered?: A Statement from the International Committee of Medical Journal Editors,” will be released on www.ICMJE.org and on individual journal Web sites on May 23 at 5 p.m. EDT.

“Our first editorial [in September 2004] was a wake-up call for researchers, trial authors and sponsors,” said Harold Sox, MD, 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 editorial tells researchers that they must not leave out key information when they register a trial. Specifically, ICJME says that researchers must name the treatment in a meaningful way so that patients and others know what intervention is under study.

The editorial also advises authors not to “use meaningless phrases to describe key information.”

Cut the bull in other words!