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September 14, 1984

The Impact of Randomized Clinical Trials on Health Policy and Medical Practice: Background Paper

Author Affiliations

National Institute of Child Health and Human Development National Institutes of Health Bethesda, Md

JAMA. 1984;252(10):1350-1351. doi:10.1001/jama.1984.03350100066037

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The randomized clinical trial (RCT) is well established among research methodologies, especially in the evaluation of new drugs. Its use for other problems is often more controversial. Advocates point out the theoretical advantages that make positive results obtained by this method so convincing. They stress the doubtful reliability of clinical observation and of descriptive studies, and, to support their position, they keep a list of harmful practices that have been perpetuated for lack of timely RCTs. Detractors emphasize the expense, the attendant time lags, the unrealistic rigidity of protocols, the lack of representativeness of volunteers, potential ethical problems, and the inability of modest-sized trials to detect important effects. They point out that most of the major advances in 20th-century medicine have not been subjected to randomized trials. Indeed, the more substantial the breakthrough, the less the need for an RCT to document its value.

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