Bleeding Academic Research Consortium Consensus Report

Abstract

The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is responsible for ensuring the safety and effectiveness of human drug products. CDER recognizes the value of therapeutic agents and encourages innovation in their development. CDER tries to ensure that approved drugs are accompanied by labeling that describes the benefits and risks of the drugs and provides good directions for use. Article see p 2736 CDER has a continuing interest in ensuring the quality of clinical trials, both because better trials will produce results that are reliable, and because they will be more efficient, ie, more likely to show a useful effect when there is one. One important way to improve the quality and efficiency of clinical trials and to enable consideration of multiple trials is through the development of standardized end point definitions. The Bleeding Academic Research Consortium (BARC) is an example of such efforts. An independent group, BARC includes members of academic research organizations, cardiovascular professional societies, pharmaceutical and cardiovascular device manufacturers, the National Institutes of Health, and the FDA (CDER and Center for Devices and Radiological Health). The FDA participated in a 1-day meeting in February …