期刊
COMMUNICATIONS IN STATISTICS-THEORY AND METHODS
卷 39, 期 20, 页码 3717-3738出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/03610920903353709
关键词
Adaptive designs; Power; Sample size re-estimation
资金
- National Institutes of Health [NCI R01-CA095749-01A1, U54-DE019261, NCRR K30-RR022258, NHLBI R01-HL091005, NIAA R01-AA016549]
- NATIONAL CANCER INSTITUTE [R01CA095749] Funding Source: NIH RePORTER
An internal pilot with interim analysis (IPIA) design combines interim power analysis (an internal pilot) with interim data analysis (two-stage group sequential). We provide IPIA methods for single df hypotheses within the Gaussian general linear model, including one and two group t tests. The design allows early stopping for efficacy and futility while also re-estimating sample size based on an interim variance estimate. Study planning in small samples requires the exact and computable forms reported here. The formulation gives fast and accurate calculations of power, Type I error rate, and expected sample size.
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