ABSTRACT

The selection of appropriate endpoints for a clinical trial is an extremely important step in determining the appropriate design and analysis for the trial [106, 107]. An endpoint is ordinarily taken to mean an efficacy endpoint, a measure of the clinical efficacy of the treatments under consideration, although safety endpoints are also important. In this chapter we focus primarily on the key efficacy endpoints commonly used in cancer clinical trials, describing their strengths and weaknesses and, where appropriate, controversies surrounding their use.