ABSTRACT
The design and analysis of clinical trials is fertile soil for statistical applications. The use of sound statistical principles in this area is particularly important because of close FDA involvement, in addition to crucial public health issues which are consequences of actions based on the outcomes of clinical experiments. Principles and procedures of experimental design, particularly as applied to clinical studies, are presented. Relatively few different experimental designs are predominantly used in controlled clinical studies. In this chapter we discuss several of these important designs and their applications.
