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- Title
The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials.
- Authors
Eapen, Zubin J.; Lauer, Michael S.; Temple, Robert J.
- Abstract
The authors discuss a working group convened in May 2013 by the public-private partnership Clinical Trials Transformation Initiative to identify barriers to the conduct of large, simple clinical trials. Topics addressed include enlarging the risk-benefit balance of therapies, making trials simpler to bring a treatment to market faster, and the need to randomize studies for most therapies. Also mentioned are advances made by the U.S. Food and Drug Administration (FDA) to streamline trials.
- Subjects
CLINICAL trials; CLINICAL medicine research; RANDOMIZED controlled trials; MEDICAL research; UNITED States. Food &; Drug Administration; CONFERENCES &; conventions
- Publication
JAMA: Journal of the American Medical Association, 2014, Vol 311, Issue 14, p1397
- ISSN
0098-7484
- Publication type
Opinion
- DOI
10.1001/jama.2014.1030