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March 1985

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

Author Affiliations

Bethesda, Md


Background Paper, Congress of the United States, Office of Technology Assessment, 109 pp, Washington, DC, US Government Printing Office, 1983, $5.

Arch Ophthalmol. 1985;103(3):332. doi:10.1001/archopht.1985.01050030028014

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This concise background paper from the Office of Technology Assessment of the US Congress covers a number of topics that are of scientific and potentially economic significance to clinical researchers and practicing ophthalmologists.

First of all, this report, prepared by Hellen Gelband on the basis of a thorough literature review and interviews with many leading scientists and administrators in clinical research, is highly informative and provocative. She peppers the text with numerous interesting examples drawn from experiences with clinical trials, provides an excellent bibliography and a modest glossary, and includes material on related issues from numerous sources. Particularly noteworthy in this regard is her inclusion of a description of the "five behavioral pitfalls" that affect physicians' application of scientific findings to patient management (p 11), a clearly presented section on the role of randomized clinical trials in the regulation of drugs and devices (pp 31 ff), a review of the

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