Randomization Designs in Comparative Clinical Trials
Ellenberg, Susan S.
New England Journal of Medicine. 1984 May 24; 310(21): 1404-1408.
Difficulties with recruiting patients for conventional randomized clinical trials have been blamed in part on physicians' discomfort with obtaining informed consent without being able to tell patients which treatment will be received. Prerandomization, in which consent is obtained after a patient has been randomly assigned to a treatment group, has been proposed as a means of increasing physician and patient participation. Ellenberg discusses the scientific, ethical, and practical problems of "double-consent randomized design," a prerandomization mechanism recently used in several multicenter cancer trials. She recommends that prerandomization be used only as a last resort to increase patient accrual, and that it be carefully evaluated. (KIE abstract)
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