Bill for national trials registry on the table

Democrat senators consider bill 

A federally funded national clinical trials registry may soon be a reality if the American Medical Association (AMA) and several Democratic senators have their way.

Representatives from the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry — both member organizations of the AMA — met June 24 with staff members from the offices Sens. Edward Kennedy (D-MA), Tim Johnson (D-SD), and Christopher J. Dodd (D-CT).

The meeting was just a preliminary step, representatives from the organizations and the government officials told The New York Times the day before the meetings.1 But the meeting followed closely on the heels of a vote by the AMA’s House of Delegates proposing that the Department of Health and Human Services (HHS) develop a national database of all completed U.S. clinical trials to include both favorable and unfavorable results.

Kennedy already has indicated he intends to introduce legislation calling for a federally run trial database, to be included in legislation aimed at offering more protections for people participating in medical research.

The AMA proposal, adopted on June 15, calls for HHS to establish a national clinical trials registry, compiling information on the outcomes of all clinical trials and making it publicly available. The proposal also urged all institutional review boards, should the registry be established, to make participation in the registry a condition of protocol approval.

"The AMA is calling on the Department of Health and Human Services to create a comprehensive, centralized clinical trials registry so that scientists, investigators, and clinicians can easily find information on trials," said AMA Trustee Joseph M. Heyman, MD, in a statement announcing the proposal’s adoption. "Posting the results of such trials would address growing concerns over publication and outcome bias in clinical trials. The AMA further calls on all institu

tional review boards to make registration in this database a condition of approval."

In recent years, there has been growing concern that the reluctance of investigators and pharmaceutical sponsors to publish the results of unsuccessful clinical trials has prevented clinicians and patients from obtaining complete information about recently approved drugs. Some experts estimate that as much of 50% of all clinical trial results never see the light of day because study sponsors bury results that are not favorable to the product.

Last month, New York’s state Attorney General, Eliot Spitzer, filed a lawsuit against pharmaceutical manufacturer GlaxoSmithKline PLC (GSK) alleging that the drug maker had, since 1998, withheld negative trial information about the antidepressant Paxil’s side effects in children and adolescents, and misinformed its sales staff about its effectiveness. Following the filing, GSK published the previously unreleased trial results on its web site.

The day after the AMA’s proposal was adopted, the Whitehouse, NJ-based pharmaceutical giant Merck and Co. announced it would support expanding a current NIH trial registry to include all drugs.

Proprietary constraints 

Currently, all drug companies must submit all clinical trial results to the FDA, but the agency is prohibited from disclosing all of the information because it is considered proprietary — the property of the company — and officials must receive the consent of the company before making the information public.

In rare instances, FDA officials have decided to publicize information that it deems necessary for the public to know for their own safety.

The federal government already has some existing trial registries — the NIH-sponsored ClinicalTrials.gov and the consumer-oriented MedLinePlus.gov regularly publish the results of completed trials. The National Cancer Institute also publishes findings from federally funded cancer clinical trials on its web site, Cancer.gov.

The AMA’s proposal would go farther in requiring the results of all clinical trials to be published in one centralized, universally accessible site.

The International Committee of Medical Journal Editors, which includes 12 major medical publications such as the New England Journal of Medicine and the Journal of the American Medical Association, also is working on a proposal that is to be completed this summer or fall. The proposal would require registration of all clinical trials in a public database or registry as a condition for publication consideration.

Reference

 1. Meier B. Democrats take a look at drug tests. The New York Times, June 23, 2004:p. 4/section C.