Analysis of Clinical Trials Using SAS, 2nd Edition

Chapter 1

Model-based and Randomization-based Methods

Alex Dmitrienko (Mediana)

Gary G. Koch (University of North Carolina at Chapel Hill)

1.1 Introduction

1.2 Analysis of continuous endpoints

1.3 Analysis of categorical endpoints

1.4 Analysis of time-to-event endpoints

1.5 Qualitative interaction tests

1.6 References

This chapter discusses the analysis of clinical endpoints in the presence of influential covariates such as the trial site (center) or patient baseline characteristics. A detailed review of commonly used methods for continuous, categorical, and time-to-event endpoints, including model-based and simple randomization-based methods, is provided. The chapter describes parametric methods based on fixed and random effects models as well ...