Journal
DRUG INFORMATION JOURNAL
Volume 35, Issue 4, Pages 1401-1408Publisher
SAGE PUBLICATIONS INC
DOI: 10.1177/009286150103500436
Keywords
interim analysis; sample size review; sample size adjustment; equivalence trial; control of the type I error rate
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To overcome the problem of uncertainty in the planning phase of clinical trials, study designs have been proposed that allow for mid-course reestimation of the sample size. Using a study in asthma patients, we illustrate how blind sample size adjustment can be performed in an equivalence trial. Thereby, we demonstrate how the type I error rate can be controlled. Further we show that the well-known expectation-maximization algorithm-based procedure by Gould and Shih is inappropriate for the purpose of sample size reestimation.
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