Magazine article Clinical Psychiatry News

Physician Groups Still Support Trials Registry

Magazine article Clinical Psychiatry News

Physician Groups Still Support Trials Registry

Article excerpt

WASHINGTON -- The pharmaceutical industry's new Web-based database on U.S. clinical drug trial results does not eliminate the need for required trial registration, physician groups contend.

On Oct. 1, the Pharmaceutical Researchers and Manufactures of America (PhRMA) released www.clinicalstudyresults.org. a Web site that aims to provide trial results in a more user-friendly format to physicians and patients.

The site is part of a longer, ongoing initiative to increase transparency in the clinical trial process, Caroline Loew, Ph.D., PhRMA's vice president for scientific and regulatory affairs, said at a press briefing to announce the database.

Several medical groups that were informed of PhRMA's new site praised the organization for presenting the data in a format useful for the practicing physician.

Dr. Ronald M. Davis, a trustee of the American Medical Association, acknowledged that the database "is a step in the right direction toward greater transparency in the clinical trial process for marketed drug products." PhRMA should be commended for no longer accepting the status quo on disclosure of trial results, Dr. Davis said.

But to truly benefit patients, "the AMA believes a centralized clinical trials registry, which includes a mechanism to ensure trial registration, is necessary." Dr. Davis said.

The AMA in recent congressional testimony outlined its ideas on what a registry should look like. Among other things, it should include phase II and III clinical trials in support of a new drug, biologic, or device application as well as postmarketing studies and other trials designed to test a therapeutic intervention.

To ensure that clinical trials are reported to the registry, institutional review boards should require registration as a condition of approval, the AMA suggested.

A public registry would complement PhRMA's venture, a mandatory component to serve as a reference point for all clinical trials taking place, Dr. Darrel A. Regier, director of research for the American Psychiatric Association, told this newspaper.

Editors of major medical journals also are pushing for a more formal process to track clinical trials.

In the Sept. 15 issue of the Journal of the American Medical Association, the International Committee of Medical Journal Editors (ICMJE) outlined a new policy requiring registration in a public trials registry for clinical studies involving human patients, as a condition of consideration for publication.

"Selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision making," the editorial stated.

The lack of a comprehensive tracking system for reporting results has resulted in a "persistent bias" in favor of positive results, and in favor of the newer and more expensive treatments, Dr. Drummond Rennie, a deputy editor at JAMA, stated in an accompanying commentary in the journal. "Another consequence is that harmful effects found in unpublished trials disappear without a trace, since the U.S. Food and Drug Administration has no mandate to report them to the public."

Under this policy, trials would have to register at or before the onset of patient enrollment. The policy would apply to any trial that begins enrollment after July 1, 2005.

The ICMJE made it clear that the registry should be accessible to the public at no charge, and managed by a not-for-profit organization.

That is also the aim of PhRMA's database, though "we haven't yet decided who we'll transition the Web site to," Dr. Loew said. "We're going forward in identifying a suitable organization. …

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