Randomized consent designs for clinical trials: an update.

Authors: Zelen M (1)
Affiliations:
(1) Harvard School of Public Health and Dana-Farber Cancer Institute, Department of Biostatistics, Harvard School of Public Health
Source: Stat Med. 1990 Jun;9(6):645-56.
DOI: 10.1002/sim.4780090611 Publication date: 1990 Jun E-Publication date: Oct. 12, 2006 Availability: abstract Copyright: © 1990 John Wiley & Sons, Ltd.
Language: English Countries: Not specified Location: Not specified Correspondence address: Not specified

Keywords

Article abstract

Randomized consent designs were introduced to make it easier for physicians to enter patients in randomized clinical trials. Physician reluctance to participate in randomized clinical trials is often a reflection that the physician-patient relationship could be compromised if the physician makes known to the patient his/her inability to select a preferred therapy. Clinical trials having a no-treatment control or placebo amplify this concern. This paper reviews the main ideas of randomized consent designs (single and double) and the statistical model underlying the analysis, and presents some recent experiences.

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