Federal Database of Clinical Trial Results Likely, NIH Director Elias Zerhouni Says
NIH Director Elias Zerhouni on Thursday at a meeting with Massachusetts General Hospital physicians said that the federal government likely would establish a database of clinical trial results in the near future and that pharmaceutical companies likely would agree to participate, the Boston Globe reports (Mishra, Boston Globe, 6/25). Zerhouni made the statement after several calls in recent weeks for the disclosure of all clinical trial results. The American Medical Association last week approved a resolution that calls on the federal government to establish such a database. The resolution seeks to provide physicians and patients with more information about the medications tested in clinical trials, such as potential side effects not mentioned in public literature, and to make public both positive and negative results.
In addition, 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, has begun to draft a proposal that would require registration of all clinical trial results in a public database or registry as a condition for publication consideration. Pharmaceutical companies currently must submit all clinical trial results to FDA, but the agency cannot disclose all of the information, which is considered proprietary. FDA officials in most cases must obtain consent from pharmaceutical companies before they can make clinical trial results public (California Healthline, 6/21). According to the Globe, to establish a federal database of clinical trial results, Congress likely would have to pass legislation that would authorize FDA to release the information and provide operational funds.
Zerhouni said that NIH analysts have told him a federal database of clinical trial results faces "no impediment." Zerhouni said, "I don't really see why (drug companies) wouldn't do it. They'll probably go along." In addition, Zerhouni said, "At pharmaceutical companies, you can find tons of data that's not being exploited" for the development of new treatments, adding, "Negative findings are as important as positive findings." Court Rosen, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said the pharmaceutical industry has concerns that such a database could lead to the disclosure of proprietary information. He said, "Obviously, we think this is a serious matter. We look forward to sitting down with the AMA and talking about clinical trial registries." FDA spokesperson Jason Brodsky said, "The FDA doesn't have the authority or funding to maintain a public listing of all clinical trials." However, he said, "We do recognize that a public listing could be invaluable to physicians" (Boston Globe, 6/25).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.