title: Power and sample size determination in clinical trials with multiple primary continuous correlated endpoints.
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.
authors.affiliation: a Department of Mathematics and Statistics , Université of Montréal , Quebec , Canada.
authors.forename: Pierre
authors.initials: P
authors.lastname: Lafaye de Micheaux
authors.forename: Benoit
authors.initials: B
authors.lastname: Liquet
authors.forename: Sébastien
authors.initials: S
authors.lastname: Marque
authors.forename: Jérémie
authors.initials: J
authors.lastname: Riou
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003198:Computer Simulation / Q000706:statistics & numerical data; D023381:Endpoint Determination / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D018401:Sample Size