Progress made on drug trial registry

The AMA has released details on what a centralized database should include, and leading medical journals have said if a study isn't registered, it won't get published.

By Victoria Stagg Elliott — Posted Sept. 27, 2004

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The movement toward easier access to clinical trial information is gaining momentum as medical societies, medical publishing and the pharmaceutical industry all take steps towards that end.

The American Medical Association, which in June called on the Dept. of Health and Human Services to establish a centralized clinical trials registry, released to Congress earlier this month its initial guidance on how such a registry should work. For instance, it should include identifying information and links to the results of phase II, phase III and post-marketing studies for all drugs, biologics, medical devices and medical interventions. Registration should be mandated by institutional review boards as a condition for approval, and the database should be easily accessible by the public.

"Currently, there are about 350 registries, and they vary substantially," said AMA Trustee Ronald M. Davis, MD. "We think it would be much easier for researchers, physicians and the general public to access this information if there is a one-stop shopping registry."

The hope is that such a resource will prevent researchers from duplicating each other's efforts, physicians from making treatment decisions without all the relevant data, and patients from missing the opportunity to participate.

"Physicians need complete and unbiased information about the safety and effectiveness of the treatments they prescribe," said Dr. Davis.

On the drug company side, several pharmaceutical companies have announced their intention to register trials either on their own Web sites or in existing registries. The Pharmaceutical Research and Manufacturers of America, the trade association for drug companies, will launch its own clinical trials database Oct. 1. It will be voluntary and include links to published studies and summaries of unpublished results of phase III and phase IV trials.

Those who have long worked on the issue, however, say that the efforts of PhRMA and individual pharmaceutical companies, while a step in the right direction, still fall short of what is needed: one mandatory, centralized, comprehensive database that would prospectively register all trials. It's unlikely, for example, that PhRMA's registry would include many details regarding nondrug interventions or early studies and would not include trials that were not funded by drug companies.

"I would like to see one, central registry that includes trials supported by pharmaceutical companies as well as trials supported by government agencies or private foundations," said David Fassler, MD, a member of the American Academy of Child and Adolescent Psychiatry and of the AMA House of Delegates. "There also needs to be an enforcement mechanism and some independent oversight to make sure that the data is consistent and accurate and complete."

The government already runs several registries, although only trials for life-threatening illnesses are required to sign up. There has long been talk in some circles about expanding this mandate, although pressure intensified recently because of allegations that information regarding antidepressants may have been concealed. Legislation that would expand this mandate to all trials was expected to be introduced in Congress this month.

Until registration is mandated, those involved in the clinical trial process are exploring other means of encouraging registration. Also this month, the International Committee of Medical Journal Editors officially adopted a policy to be phased in next year that its members would no longer publish papers from trials that were not registered prospectively. ICMJE members include the Journal of the American Medical Association, the New England Journal of Medicine and The Lancet. Advocates expect the policy to trickle down to others.

"When the top journals adopt something, they are rapidly followed by a ton of other journals," said Drummond Rennie, MD, deputy editor of JAMA.

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External links

"Clinical Trial Registration, A Statement From the International Committee of Medical Journal Editors," Journal of the American Medical Association, Sept. 8 (link)

The National Institutes of Health's clinical trials database (link)

The Pharmaceutical Research and Manufacturers of America's clinical trials registry (link)

AMA Council on Scientific Affairs' report, "Influence of Funding Source on Outcome, Validity and Reliability of Pharmaceutical Research," June (link)

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