Forum on Drug Discovery, Development, and Translation: Annual Report 2009 (2010)

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Transforming clinical research Transforming Clini cal Rese The Forum recognizes that the critical link between scientific discovery and medical utility is clini- cal trials—testing whether or not a new therapeutic product performs as expected and makes a difference in treating disease. To plan and execute a clinical trial today can take years and cost hundreds of millions of dollars. To engage stakeholders in an honest discussion of the state of clinical trials in the United States today and gain an understanding of the challenges to conduct- ing clinical trials, the Forum held the first in a series of workshops in October 2009. Workshop participants identified areas of strength and weakness in our current clinical trials enterprise, and considered transformative strategies for enhancing the ways in which clinical research is organized and conducted. The next workshop, planned for 2010, will address proposals for a national clinical research infrastructure in the United States to effectively bridge the divide be- tween clinical research and clinical practice. The Forum will also bring this important discussion arch to a broader audience of policymakers, practicing clinicians, academic researchers, and patients across the United States through a sub-series of regional meetings on clinical research. May – Workshop on Understanding the Benefits and Risks of Pharmaceuticals 2006 June – Workshop on Addressing the  Barriers to Pediatric Drug Development 

Transforming Clinical Research in the United States Transforming Clini cal Rese The Forum launched a series of workshops to examine the state of clinical trials in the United States. The workshop series seeks to iden- tify strengths and weaknesses in the existing clinical trials enterprise, and consider transformative strategies for enhancing the ways in which clinical research is organized and conducted. The first work- shop, held in October 2009, examined four disease areas—cardio- vascular disease, depression, cancer, and diabetes—to explore how Forum member Robert Califf clinical research approaches vary by disease, and to identify lessons from these examples that can be applied to clinical research in other disease areas. Presentations are avail- able on the Forum website, and a workshop summary will be released in 2010. arch Depression Panel at the Clinical Trials Workshop: William Potter, Merck; Madhukar Trivedi, Southwestern Medical Center; Jim McNulty, Depression and Bipolar Disorder Alliance; Amir Kalali, Quintiles March – Symposium on the IOM Drug September – Biomedical Science and Policy Safety Report and Challenges for the FDA Discussion Series, “Patient-Driven Drug Discovery and Development” 2007 April – Workshop on November – A Conversation Emerging Safety Science with Tony Fauci