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Power and sample size determination in clinical trials with multiple primary continuous correlated endpoints
Pierre Lafaye de Micheaux1, Benoit Liquet, Sébastien Marque
1a Department of Mathematics and Statistics , Université of Montréal , Quebec , Canada.
Abstract:
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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