Analysis of Stratified Data     1



1.1 Introduction

1.2 Continuous Endpoints

1.3 Categorical Endpoints

1.4 Time-to-Event Endpoints

1.5 Tests for Qualitative Interactions

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 ...

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