Introduction to Composite Endpoints

Abstract

This chapter is the first of seven consecutive chapters that applies the multiple analyses methodology that we have developed thus far to specific, complex circumstances that commonly occur within modern clinical trials. Both this and the next chapter focus on the use of the composite or combined endpoint as a primary analysis variable. Composite or combined endpoints are defined as the combination of component (singleton) endpoints, each of which has clinical significance in its own right. In this chapter, the complications involved in the construction of the composite endpoint are discussed, and the issue of homogeneity versus heterogeneity of treatment effect is addressed.