Dec 28 2004
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 that has long existed within the FDA," said Turner. "This would provide a lot of bang for the taxpayer buck.
"If a drug company wants to market a drug for a particular use or indication in the U.S., it must do studies and prove to the FDA that it is safe and effective for that indication. But before it can do those studies, it must register them with the FDA. Because the FDA is made aware of these studies in advance, the study sponsor cannot pretend that a study that turned out negative did not exist. So the FDA reviews all major studies, positive or negative, published or unpublished.
"In accordance with the Electronic Freedom of Information Act, over the past several years, the FDA has been posting the review documents for some approved drug-indication combinations on its Web site. Unfortunately, these reviews are only sporadically available. I believe that the FDA could make all -- not just some -- NDA [new drug application] reviews, at least for approved NDAs, available in the public domain," said Turner. Staffing at the FDA might need to be increased,, acknowledged Turner. Also, simple formatting changes could make the FDA reviews much more user-friendly, he said.
"The idea of an FDA clinical trial results database could be complementary to proposals by the American Medical Association (AMA) and other groups," Turner explained. The AMA, for example, has proposed creation of a registry that is comprehensive, whereas the FDA registry and results database would be restricted to those trials aimed at supporting U.S. drug marketing approval or a change in labeling in the United States.
"Despite the limitations of the FDA's database, making it public is a strategy that could be implemented both rapidly and easily by building upon existing infrastructure," said Turner. "While we wait for new proposals, such as the AMA's, to be implemented, we already have at our disposal a trove of in-depth and unbiased information on many, if not most, drugs currently marketed in the United States. This would provide health care providers, researchers and the public with a more balanced and complete view of the efficacy and safety of our drugs. It should ultimately benefit the public health."
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