ABSTRACT

Phase II dose-finding studies play an important role in drug development. They are the last study/studies before the confirmatory studies in Phase III start. By this, they have an important role not only in supporting the go/no-go decision to Phase III but also in terms of dose finding and dose selection for Phase III clinical trials. While the first two parts of this book primarily focused on dose finding in Phase I safety trials, this part considers situations where dose selection is determined primarily by efficacy studies as they are conducted in late Phase II. The purpose of Part III is to give a practical overview of model-based methods for analysis and design of dose-finding studies in Phase II. This chapter provides an overview of dose finding in Phase II in general and contains an outlook on the following chapters in this part. See also Table 11.1 for a summary.