Medical journals push for release of all clinical trial results

September 9, 2004

Last Updated Wed, 08 Sep 2004 21:59:42 EDT

TORONTO - Some of the world's most prestigious medical journals have banded

together to force pharmaceutical and medical device companies to report the

full results of clinical trials, both positive and negative.

The 11 publications, which include the Canadian Medical Association

Journal, the Lancet and the New England Journal of Medicine, are demanding

that all clinical trials be registered in a free public database before

researchers begin enrolling patients. Otherwise, they won't publish the study.

The new policy, announced on Wednesday by the International Committee of

Medical Journal Editors, will take effect in July 2005.

" The journals' reasons are primarily to make sure that the information

that's coming forward on these clinical trials is all the information – not

just the good part of it, " said Dr. John Hoey, editor of the Canadian

Medical Association Journal.

Hoey said there are an increasing number of instances of studies on

patients that are sponsored by drug or medical device companies that never

come to light if results are negative.

In other cases, only the positive results are submitted to medical journals

for publication.

The journal editors said " selective reporting " of results distorts the body

of evidence on drugs and treatments available to doctors, and is also a

disservice to patients who have volunteered to participate in the studies.

" We want the research that's done on patients to be in the public domain, "

said Dr. Jeffrey Drazen, editor-in-chief of the New England Journal of

Medicine.

" Clinical research is different from any other kind of industrial research

in that it's a partnership between patients and industry, " he said.

" The patient in some cases is literally putting their life on the line, "

Drazen said. " And right now, the industry has held all the cards and kept

everything secret until they wanted to report it. "

The association representing U.S. pharmaceutical companies announced

Tuesday that it is establishing an online data base where members will be

able to post information about " completed clinical trials. "

The organization that represents Canada's drug companies says it's " still

developing an industry position. "

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