期刊
BIOMETRIKA
卷 87, 期 1, 页码 125-134出版社
BIOMETRIKA TRUST
DOI: 10.1093/biomet/87.1.125
关键词
clinical trial; error-spending function; group sequential test; interim monitoring; internal pilot; resizing; sample size calculation; t-test; unknown variance
If the maximum sample size for a group sequential t-test is calculated on the basis of a prior estimate of the variance, power at a fixed distance from the null hypothesis is not robust to misspecification of the variance. We propose a new group sequential t-test, based on Stein's (1945) two-stage test, in which we use internal estimates of the variance to update the maximum sample size, and allow early stopping to reject the null hypothesis through a Lan & DeMets (1983) error-spending function. We evaluate our procedure's performance and show that it closely controls the type I and II error rates.
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