ABSTRACT
This chapter discusses statistical considerations in the design and analysis of phase II dose-ranging studies. It describes a Bayesian procedure for evaluating predictive precision in the estimate of the minimum effective dose and predictive assurance in testing the Hypotheses. A dose-ranging study is a clinical trial in which two or more doses of a drug are tested to determine the most effective and safe dose to be used in the Phase III confirmatory trials. Phase II dose-ranging clinical trial designs have evolved to include more dose groups and focus on the modeling of a dose–response curve. While the use of a dose–response curve conforms to the needs of the clinician, one difficulty is that the shape of the curve is usually unknown a priori to the Phase II study. The chapter demonstrates the utility of Bayesian methods in dose-ranging studies and ease of its implementation in support of study design and analysis.
