[20050214]RS21944_临床试验报告和出版.pdf

Congressional Research Service The Library of CongressCRS Report for CongressReceived through the CRS WebOrder Code RS21944Updated February 14, 2005Clinical Trials Reporting and PublicationErin Williams and Susan ThaulSpecialists in Social LegislationDomestic Social Policy DivisionSummaryIn 2004, concerns arose that certain antidepressants, other medicines (e.g., Vioxx),and medical devices (e.g., coronary stents), had been marketed to consumers despiteunresolved safety issues. Data from clinical trials conducted both before and after aproduct goes to market are central to assessing its safety and effectiveness, but there iscurrently no centralized system for reporting results. Due to medical journal practicesand drug sponsor and researcher incentives to publicize positive results, many trials withinconclusive or negative results are not publically reported. Although Food and DrugAdministration (FDA) regulations require sponsors of trials that test the effectivenessof new drugs for serious or life-threatening conditions to register with the Departmentof Health and Human Services (HHS) at clinicaltrials.gov, not all such trials are listedthere. A voluntary registry of recent controll