Power and Sample Size Determination in Clinical Trials with Multiple Primary Continuous Correlated Endpoints

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.