This chapter discusses the analysis of clinical outcomes in the presence of influential covariates such as investigational center or patient demographics. The following analysis methods are reviewed:
• Stratified analyses of continuous endpoints using parametric methods based on fixed and random effects models as well as nonparametric methods.
• Simple randomization-based methods as well as more advanced exact and model-based methods for analyzing stratified categorical outcomes.
• Analysis of stratified time-to-event data using randomization-based tests and the Cox proportional ...