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Envisioning a Transformed Clinical Trials Enterprise in the United States

Establishing An Agenda for 2020

Workshop Summary


Washington (DC): National Academies Press (US); .
ISBN-13: 978-0-309-25315-4ISBN-10: 0-309-25315-2


Recognition is growing that the clinical trials enterprise (CTE) in the United States faces substantial challenges impeding the efficient and effective conduct of clinical research to support the development of new medicines and evaluate existing therapies. A gap has been identified between the desired state where medical care in the United States is provided solely based on high-quality evidence—and the reality—where we have limited ability to generate timely and practical evidence. There have increasingly been calls for transformation of the CTE in the United States to support the efficient development of breakthrough medicines and interventions and the evidence needed for health care decision making. Leaders in research and health care convened to discuss this visionary quest at a 2-day workshop held in November 2011 by the Institute of Medicine (IOM) Forum on Drug Discovery, Development, and Translation.

The workshop focused primarily on one type of clinical investigation, randomized controlled trials (RCTs)


Rapporteurs: Neil Weisfeld, Rebecca A. English, Anne B. Claiborne

This study was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (Contract Nos. N01-OD-4-2139 TO #158 and HHSF223001003T), American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, Bristol-Myers Squibb, Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly & Co., FasterCures, Foundation for the NIH, Friends of Cancer Research, GlaxoSmithKline, Janssen Research & Development, LLC, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, and Pfizer Inc.

Suggested citation:

IOM (Institute of Medicine). 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press.

The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

Copyright © 2012, National Academy of Sciences.
Bookshelf ID: NBK92275PMID: 23236648DOI: 10.17226/13345


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