[Reappraisal of Zelen's method in randomized controlled trials].
This paper discusses Zelen's method (a study design with pre-randomization) in randomized controlled trials from the following aspects: 1) compliance of patients with a randomly assigned treatment; 2) infringement of patients' right to choose treatments; and 3) unfairness that only patients assigned to a new treatment are allowed a choice of treatments. The reason Zelen's method is rarely used in the United States or European countries seems to be the lower compliance of treatments in Zelen's method than in the conventional design of randomized controlled trials. Considering the present study practice in Japan, where study subjects are not completely informed by randomized assignment of treatments, Zelen's method is thought to be more practical, and not inferior to the conventional design in terms of compliance.
Hamajima
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Dept. of Public Health, Gifu University School of Medicine, Japan.
D006801:Humans; D007258:Informed Consent; D010349:Patient Compliance; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design