The International Committee of Medical Journal Editors will propose making registration of clinical trials at inception a prerequisite for publication of results in an editorial slated for release Sept. 9.

Making clinical trial registration a condition for publication would add teeth to calls from the medical profession for broader use of registries.

ICMJE members include the Journal of the American Medical Association, The New England Journal of Medicine and The Lancet.

Merck Executive Director-Medical Communications Larry Hirsch, MD, discussed the upcoming journal committee action during an Institute of Medicine Clinical Research Roundtable in Washington, D.C. Sept. 2.

"There will be, probably in the next two weeks or so...an editorial that will be published simultaneously in the 11 or 12 journals that are the members of the ICJME calling for mandatory registration of clinical trials at their inception as a condition for the journals to even consider publication of the results of such trials at the time the study is complete," Hirsch said.

Merck opposes mandatory registration of clinical trials at their inception, Hirsch said.

"Merck has proposed a possible expansion of www.ClinicalTrials.gov to include all hypothesis-testing Phase III and post-marketing trials, in other words to go beyond the mandate right now to limit it to serious, life threatening conditions," he said (¹ Also see "Merck Support For ClinicalTrials.Gov Expansion Does Not Mean Company Will Add Listings" - Pink Sheet, 21 June, 2004.).

"Nevertheless, we remain opposed to mandatory registration of all clinical trials at their inception."

"I'm troubled by the idea that there is an inherent assumption of almost misconduct or surreptitious behavior or something if you turn in a manuscript on a well designed, well done trial and you haven't registered it and then the journal editor is going to say, sorry, we're not going to consider this for publication," he stated.

Merck is developing a response to the journals' proposal, Hirsch said. "All I can say is stay tuned."

- Adam Eckstein

Medical Journals To Propose Making Trial Registry Condition For Publication

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