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, AMNews staff. Sept. 27, 2004.

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.