期刊
BIOMETRICAL JOURNAL
卷 49, 期 6, 页码 903-916出版社
WILEY
DOI: 10.1002/bimj.200610373
关键词
clinical trials; internal pilot study; non-inferiority study; nuisance parameter; sample size reestimation
Sample size calculations in the planning of clinical trials depend on good estimates of the model parameters involved. When the estimates of these parameters have a high degree of uncertainty attached to them, it is advantageous to reestimate the sample size after an internal pilot study. For non-inferiority trials with binary outcome we compare the performance of Type I error rate and power between fixed-size designs and designs with sample size reestimation. The latter design shows itself to be effective in correcting sample size and power of the tests when misspecification of nuisance parameters occurs with the former design.
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