Senators Seek FDA, NIH Advice on Clinical Trial Database
FDA and NIH officials should provide details about "what could be done" to improve, expand or create a new government-run database for all clinical drug trials, Sens. Tim Johnson (D-S.D.), Edward Kennedy (D-Mass.) and Christopher Dodd (D-Conn.) wrote in a letter to the agencies on Thursday, the New York Times reports. According to the Times, that database is "limited and essentially functions as an information resource" for potential trial participants. The letter asks for action steps to improve an existing clinical trials database, expand it or create a new one (Meier, New York Times, 7/9). Representatives of the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry last month met with staff members of the three senators to discuss legislation on the issue. Kennedy has said he plans to reintroduce a bill that would expand protections for participants in clinical trials and may also address the database issue in the legislation (California Healthline, 6/23). Kennedy spokesperson James Manley said he expects legislation to be introduced this month (New York Times, 7/9).
Other lawmakers, medical professionals and medical journal editors in recent months have called on pharmaceutical companies to disclose both the positive and negative findings of all clinical trials. World Health Organization officials on Wednesday said they plan to propose an international clinical trial registry, modeled after similar databases in the United States and other nations, to national health ministers at a November meeting (Vendantam, Washington Post, 7/8). The American Medical Association last month approved a resolution that calls on the federal government to establish a new national database. 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. Some drug companies have raised concerns about the effect of such a registry on trade secrets (California Healthline, 6/30).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.