AMA backs public registry for trials, outcomes
In The Devil’s Dictionary, contrary philosopher Ambrose Bierce characterized a physician as “one upon whom we set our hopes when ill and our dogs when well. Still, let’s give a nod to the Stethoscope Men and Women because the American Medical Association (AMA) approved a policy to urge the U.S. Dept. of Health and Human Services (HHS) to develop a public registry of all clinical trials and their outcomes.
Also, The Wall Street Journal reported, the AMA 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 reflects concerns from psychiatry groups, including the American Academy of Child and Adolescent Psychiatry, concerning unpublished studies on antidepressants and potential suicide risk, particularly among children and adolescents. The Journal stated that unpublished clinical trial results are more likely to be negative than published results, some studies have said. Critics contend doctors and patients need access to unpublished studies to guide decisions on medicines.
The AMA action is seen pressuring drug companies to release unpublished data from clinical trials, but Alan Goldhammer, associate vice president of regulatory affairs for the Pharmaceutical Research and Manufacturers of America, a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 policy. Among Dr. Goldhammer’s questions was: "What are the data elements?"
Meanwhile, editors from some medical journals, including the New England Journal of Medicine and JAMA, the AMA's journal, said they have discussed a proposal which 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, JAMA editor-in-chief. The editors' discussion of a database proposal was reported in The New York Times.
Critics argue that medical journals have a role in the paucity of published negative trial results due to a “bias for publishing positive study results, that is, studies showing that a treatment worked” the story added.
In the U.S., drug companies consider some data proprietary. By law, the U.S. Food and Drug Administration (FDA) 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.