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1 (February 14, 2005)

handle is hein.crs/crsmthabcry0001 and id is 1 raw text is: Order Code RS21944 Updated February 14, 2005 CRS Report for Congress Received through the CRS Web Clinical Trials Reporting and Publication Erin Williams and Susan Thaul Specialists in Social Legislation Domestic Social Policy Division Summary In 2004, concerns arose that certain antidepressants, other medicines (e.g., Vioxx), and medical devices (e.g., coronary stents), had been marketed to consumers despite unresolved safety issues. Data from clinical trials conducted both before and after a product goes to market are central to assessing its safety and effectiveness, but there is currently no centralized system for reporting results. Due to medical journal practices and drug sponsor and researcher incentives to publicize positive results, many trials with inconclusive or negative results are not publically reported. Although Food and Drug Administration (FDA) regulations require sponsors of trials that test the effectiveness of new drugs for serious or life-threatening conditions to register with the Department of Health and Human Services (HHS) at clinicaltrials.gov, not all such trials are listed there. A voluntary registry of recent controlled trials results was created in October 2004 by the Pharmaceutical Research and Manufacturers of America (PhRMA). Several groups have called for public access to standardized clinical trials data, including notice of trial launch and research results through a centralized system such as a registry. Proposals for registries for these purposes raise issues regarding the goals of public access, the appropriateness and presentation of information, the timing of a trial's inclusion, whether they will compromise intellectual property rights, whether reporting should be mandatory, potential conflicts of interest, and whether medical device trials should be included. In October 2004, Representative Edward Markey and Senator Christopher Dodd introduced companion bills H.R. 5252 and S. 2933, the Fair Access to Clinical Trials Act, which would have required registration of clinical trials before the enrollment of human subjects, and the subsequent posting of results, at clinicaltrials.gov or a similar forum. Similar legislation is likely to be introduced in the 109th Congress. This report will be updated on a regular basis. Introduction In 2004, Congress and others raised questions about the safety and effectiveness of several FDA-approved biomedical products on the market. These included certain antidepressants, Merck's pain relief drug, Vioxx, Boston Scientific's cardiac stents, and other drugs and medical devices. Discussion about ways to help ensure safety and Congressional Research Service **o The Library of Congress

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