A group sequential t-test with updating of sample size

被引:30
作者
Denne, JS [1 ]
Jennison, C
机构
[1] De Montfort Univ, Dept Med Stat, Leicester LE1 9BH, Leics, England
[2] Univ Bath, Dept Math Sci, Bath BA2 7AY, Avon, England
关键词
clinical trial; error-spending function; group sequential test; interim monitoring; internal pilot; resizing; sample size calculation; t-test; unknown variance;
D O I
10.1093/biomet/87.1.125
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
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.
引用
收藏
页码:125 / 134
页数:10
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