Two-stage sample size re-estimation based on a nuisance parameter: A review

被引：58
|
作者：
Proschan, MA [1 ]
机构：
[1] NHLBI, Bethesda, MD 20892 USA
来源：
JOURNAL OF BIOPHARMACEUTICAL STATISTICS | 2005年 / 15卷 / 04期
关键词：
adaptive methods; ancillary statistic; blinding; continuous outcome; clinical trials; conditioning; correlation; dichotomous outcome; independence; internal pilot study; lumping; pooling; power; restricted design; unrestricted design;
D O I：
10.1081/BIP-200062852
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
Sample size calculations are important and difficult in clinical trails because they depend on the nuisance parameter and treatment effect. Recently, much attention has been focused on two-stage methods whereby the first stage constitutes an internal pilot study used to estimate parameters and revise the final sample size. This paper reviews two-stage methods based on estimation of nuisance parameters in either a continuous or dichotomous outcome setting.
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页码：559 / 574
页数：16
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