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Envisioning a Transformed Clinical Trials Enterprise in the United States - Establishing an Agenda for 2020: Workshop Summary (Paperback)
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Envisioning a Transformed Clinical Trials Enterprise in the United States - Establishing an Agenda for 2020: Workshop Summary (Paperback)
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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. Table of Contents Front
Matter 1 Introduction 2 Integrating Community Practice and Clinical
Trials 3 Improving Public Participation in Clinical Trials 4
Creating a New Business Model for Clinical Trials 5 Building an
Infrastructure to Support Clinical Trials 6 Suggesting an Agenda
for Transforming Elements of the Clinical Trials Enterprise
References Appendix A: Workshop Agenda Appendix B: Participant
Biographies Appendix C: Registered Workshop Attendees Appendix D:
Discussion Paper: The Clinical Trials Enterprise in the United
States: A Call for Disruptive Innovation Appendix E: Discussion
Paper: Developing a Robust Clinical Trials Workforce Appendix F:
Discussion Paper: Transforming the Economics of Clinical Trials
Appendix G: Discussion Paper: Developing a Clinical Trials
Infrastructure Appendix H: Discussion Paper: Canadian Strategy on
Patient-Oriented Research Appendix I: Discussion Paper: Health
Research as a Public Good Appendix J: Discussion Paper: Novel Ways
to Get Good Trial Data: The UK Experience Appendix K: IOM Staff
Paper: Context and Glossary of Select Terms Associated with the
Clinical Trials Enterprise
General
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