Title Envisioning a transformed clinical trials enterprise in the United States : establishing an agenda for 2020 : workshop summary / Neil Weisfeld, Rebecca A. English, and Anne B. Claiborne, Rapporteurs ; Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy, Institute of Medicine of the National Academies

Published Washington, D.C. : National Academies Press, ©2012

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Description 1 online resource (xvi, 232 pages) : illustrations (some color) Series Online access: National Academy of Sciences National Academies Press Online access: NCBI NCBI Bookshelf Contents Introduction -- Integrating community practice and clinical trials -- Improving public participation in clinical trials -- Creating a new business model for clinical trials -- Building an infrastructure to support clinical trials -- Suggesting an agenda for transforming elements of the clinical trials enterprise Summary "There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop"--Publisher's description Bibliography Includes bibliographical references Notes Print version record Subject Clinical trials -- United States Clinical trials -- Economic aspects -- United States Clinical trials -- Social aspects -- United States Drug development -- United States Drugs -- Testing. Pharmaceutical industry -- United States Business and medicine -- United States Drugs -- Design. Pharmaceutical industry. Randomized Controlled Trials as Topic -- United States -- Congresses Clinical Trials as Topic -- United States -- Congresses Drug Design -- United States -- Congresses Drug Industry -- United States -- Congresses Clinical Trials as Topic Drug Design Randomized Controlled Trials as Topic Drug Industry Drugs -- Design Pharmaceutical industry Drugs -- Testing Drug development Business and medicine Clinical trials SUBJECT United States Subject United States Genre/Form proceedings (reports) Conference papers and proceedings Conference papers and proceedings. Actes de congrès. Form Electronic book Author Weisfeld, Neil E English, Rebecca A Claiborne, Anne B Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation. Institute of Medicine (U.S.). Board on Health Sciences Policy LC no. 2012474101 ISBN 9780309253154 0309253152 0309253160 9780309253161

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