Drug controversies prompt call for clinical trial registry

Advocates hope to build on existing databases to create one mega-source, including published and unpublished research.

By Victoria Stagg Elliott, AMNews staff. July 5, 2004.

When David Fassler, MD, a child and adolescent psychiatrist from Burlington, Vt., was called to review data -- much of it unpublished -- about antidepressant use by kids and teenagers for a February Food and Drug Administration hearing, he was stunned.

The information suggested that several of these drugs were not effective for depression in this age group and could actually lead to an increased risk of suicidal behavior.

"This data clearly had an impact on our own analyses, our comments and our recommendations and on the subsequent public debate," said Dr. Fassler.

The fact that the findings had not previously been accessible has focused new attention on efforts to open up the clinical trial process. Adding to this momentum are other related events, including the FDA's initial June 2003 caution regarding the antidepressant paroxetine, its expanded advisory issued in March, and a New York State lawsuit that charged the drug's manufacturer, GlaxoSmithKline, with concealing information.

Registries are one of the mechanisms currently gaining favor.

Delegates to the AMA's Annual Meeting in Chicago last month endorsed a policy that would urge the Dept. of Health and Human Services to establish a comprehensive registry for all clinical trials and require every trial to have a unique identifier.

Similarly, a proposal being considered by the International Committee of Medical Journal Editors would require all clinical trials to be listed in a registry as a requirement for publication.