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Summary:
The recent focus on public access to pediatric clinical trial data for certain selective serotonin reuptake inhibitors (SSRIs) and other antidepressants has highlighted the issues surrounding public access to clinical trial data generally. Clinical trials data are central to assessing drugs' effectiveness, yet there is no centralized system for reporting results. Due to medical journal practices and drug sponsor and researcher incentives to publicize positive results, many trials are never publically reported. Although Food and Drug Administration (FDA) regulations require applicants to register clinical trials at clinicaltrials.gov, not all trials are listed there. Several groups have called for public access to standardized clinical trials data, including notice trial launch and research results. Members of the House and Senate are pursuing legislative action and encouraging FDA regulation. Announcements of new methods to standardize data submissions and trial identification to facilitate the sharing of research information were made by the World Health Organization in June 2004, and by FDA in July 2004. In September 2004, the International Committee of Medical Journal Editors announced that their journals would only publish the results of studies that had been reported in a public registry. With increased executive, judicial, and congressional interest in clinical trial results, the pharmaceutical industry moved to make some trial results available to the public. This report will be updated on a regular basis.
