AMA Supports Public Registry For Clinical Trials, Outcomes
By a WALL STREET JOURNAL Staff Reporter
June 16, 2004; Page D2
The American Medical Association approved a policy to urge the Department of Health and Human Services to develop a public registry of all clinical trials and their outcomes.
As part of the policy, the AMA yesterday also requested that powerful institutional review boards, or IRBs, require registering in the proposed database as a condition for allowing a clinical trial to proceed. IRBs are charged with monitoring the treatment of participants in clinical trials.
The policy was drafted in response to concerns from psychiatry groups, including the American Academy of Child and Adolescent Psychiatry, over unpublished studies on antidepressants and potential suicide risk, particularly among children and adolescents.
Unpublished clinical trial results are more likely to be negative than published results, some studies have said. Critics say doctors and patients need access to unpublished studies to guide their decisions about medicines.
The AMA action boosts the pressure on drug companies to release unpublished data from clinical trials.
Alan Goldhammer, associate vice president of regulatory affairs for the Pharmaceutical Research and Manufacturers of America, a trade group for drug makers, said it was too early to say whether the group supports the AMA policy. Dr. Goldhammer said questions remained about the proposed registry. "What are the data elements?" he said.
In another step toward wider publication of negative trial results, editors from some medical journals, including the New England Journal of Medicine and JAMA, the AMA's journal, said they have discussed a proposal that would require companies to register in a clinical-trial database as a condition of publication in their journals.
Such a requirement would mean "If you start a trial, then you have to register it," said Catherine DeAngelis, editor-in-chief of JAMA. The editors' discussion of a database proposal was reported yesterday in the New York Times.
Some observers say medical journals themselves have a role in the paucity of published negative trial results. Journals, these observers say, have a bias for publishing positive study results, that is, studies showing that a treatment worked.
Drummond Rennie, professor of medicine at the University of California-San Francisco and deputy editor of JAMA, said medical-journal editors have urged the drug industry to agree to a clinical-trial registry with little success. "I've been pushing this for 10 years," said Dr. Rennie, who isn't part of the committee of editors discussing the database proposal. "It's only now that people are starting to pay attention to this."
In the U.S., drug companies consider some of the data proprietary. By law, the Food and Drug Administration can't make the data public without drug company consent. A public listing of all clinical trials isn't under the FDA's authority and would be difficult to manage, said Rachel Behrman, deputy director for medical policy at the FDA's Center for Drug Evaluation and Research.
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