A researcher at Oregon Health & Science University and the Portland Veterans Affairs Medical Center is calling upon the U.S. Food and Drug Administration (FDA) to share more information provided by pharmaceutical companies regarding their clinical drug trials. This database could be freely accessible to health care providers, researchers and the public. Such a move would be cost-effective and could work in conjunction with other national clinical registry and results database efforts already under way, said Erick Turner, M.D., assistant professor of psychiatry, and physiology and pharmacology in the OHSU School of Medicine.
Turner, a former clinical reviewer of psychotropic drugs for the FDA, put forth his recommendations in the essay "A Taxpayer-Funded Clinical Trials Registry and Results Database: It Already Exists Within the U.S. Food and Drug Administration," published online Dec. 28, 2004, in the Public Library of Science Medicine Journal, a peer-reviewed, open-access publication.
"Over the past few years, there has been growing concern about selection bias in the way clinical trials results are published," said Turner. The debate intensified, he said, with a summer 2004 lawsuit against GlaxoSmithKline alleging that company hid data regarding the safety and efficacy of serotonin reuptake inhibitors given to pediatric patients with depression.
The two most frequently suggested remedies for the selective reporting of clinical trials results have been to register all clinical trials and to make their results publicly available.
"Registries have been called for since 1974," said Turner, "and hundreds have already been established." However, said Turner, the current registries usually aren't coordinated and participation is voluntary. Consequently, not all clinical trial results are listed and those that are may be incomplete.
"I suggest that we increase public access to the clinical trials registry and results database tha
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Contact: Tamara Hargens
hargenst@ohsu.edu
503-494-8231
Oregon Health & Science University
28-Dec-2004
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