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Envisioning a transformed clinical trials enterprise in the United States : establishing an agenda for 2020

Author(s):
Weisfeld, Neil E
English, Rebecca A
Claiborne, Anne B
Institute of Medicine (US) Forum on Drug Discovery Development and Translation
Title(s):
Envisioning a transformed clinical trials enterprise in the United States : establishing an agenda for 2020 [electronic resource] / 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.
Country of Publication:
United States
Publisher:
Washington, DC : National Academies Press, c2012.
Description:
1 online resource (1 PDF file (xvi, 232 p.)) : ill.
Language:
English
ISBN:
9780309253154
0309253152
Electronic Links:
http://www.ncbi.nlm.nih.gov/books/NBK92275/
Summary:
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).
MeSH:
Clinical Trials as Topic*
Drug Design*
Drug Industry
Randomized Controlled Trials as Topic
United States
Publication Type(s):
Congresses
Notes:
Includes bibliographical references.
Issued also in print.
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.
Description based on online resource; title from PDF title page (viewed March 20, 2013).
NLM ID:
101601246 [Electronic Resource]

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