期刊
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
卷 24, 期 2, 页码 378-397出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2013.860156
关键词
Sample size determination; Power; Multiple continuous endpoints; Correlated endpoints; Family-Wise error rate; Multivariate normal distribution
资金
- Natural Science and Engineering Research Council of Canada
The use of two or more primary correlated endpoints is becoming increasingly common. A mandatory approach when analyzing data from such clinical trials is to control the family-wise error rate (FWER). In this context, we provide formulas for computation of sample size and for data analysis. Two approaches are discussed: an individual method based on a union-intersection procedure and a global procedure, based on a multivariate model that can take into account adjustment variables. These methods are illustrated with simulation studies and applications. An R package known as rPowerSampleSize is also available.
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