Randomization Designs in Comparative Clinical Trials

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Abstract
IN a conventionally conducted randomized clinical trial, random assignment to treatment does not lake place until the patient has been demonstrated to be eligible, has had the details of the study explained, including possible risks and benefits of the therapeutic alternatives, and has then agreed to participate. A modification of this randomization procedure, the "randomized-consent design," has recently been introduced into the practice of clinical trials. The intent of this new design, also called prerandomization, is to eliminate what many physicians feel to be a most uncomfortable and difficult aspect of randomized clinical trials: having to obtain the patient's consent . . .

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