PubMed · 3568693
A two-stage design for randomized trials with binary outcomes.
Abstract
A two-stage rule for a randomized clinical trial with a dichotomous outcome is presented. It is based on a rule discussed by Ellenberg and Eisenberger (Cancer Treat Rep 69:1147-1154, 1985). The rule is shown to lead to a reduction in expected sample size if the test treatment is ineffective, with almost no loss in power. All the mathematical formulas required to design such a rule are given, as well as some time-saving approximations. The accuracy of the approximations is shown.
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S Wieand, T Therneau. 1987. A two-stage design for randomized trials with binary outcomes.. https://doi.org/10.1016/0197-2456(87)90022-5
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