Doctor groups still back clinical trials registry.(Practice Trends)

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

On Oct. 1, the Pharmaceutical Researchers and Manufacturers 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 affa0irs, 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.