期刊
DRUG INFORMATION JOURNAL
卷 35, 期 4, 页码 1401-1408出版社
SAGE PUBLICATIONS INC
DOI: 10.1177/009286150103500436
关键词
interim analysis; sample size review; sample size adjustment; equivalence trial; control of the type I error rate
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.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据