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1 (September 23, 2004)

handle is hein.crs/crsmthabcrx0001 and id is 1 raw text is: Order Code RS21944 September 23, 2004 CRS Report for Congress Received through the CRS Web Clinical Trials Reporting and Publication Erin Williams Specialist in Bioethical Policy Domestic Social Policy Division Susan Thaul Specialist in Social Legislation Domestic Social Policy Division 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 theirjournals 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. Introduction The safety and effectiveness of approximately 10 antidepressants approved by the FDA for adult use have been increasingly questioned. Several of the drugs are SSRIs (selective serotonin reuptake inhibitors), such as Prozac, Zoloft and Paxil. Concerns have focused on the possibility that certain antidepressants are not effective for children and may cause an increased risk of self harm and suicidal thoughts. In September 2004, both Congress and the FDA held hearings on antidepressant use by children. Both hearings Congressional Research Service **o The Library of Congress

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