ABSTRACT
INTRODUCTION Statistical concepts clearly play a key role in both the design of clinical trials and the subsequent analysis of the clinical trial data. The purpose of this chapter is to provide a broad overview of the statistical methodology used in trials. In recent years, we have also seen the publication of numerous regulatory guidelines that directly relate to statistical issues. These build on the foundations of the general ICH E9 Guideline “Statistical Principles in Clinical Trials” (1). The material that follows in this chapter is very much motivated by what these guidelines say, and the way that methodology has developed and been applied in the pharmaceutical industry.
