ABSTRACT
This chapter presents applications of the Clinical Scenario Evaluation (CSE) approach to a general confirmatory subgroup analysis setting. It introduces the key components of the CSE framework namely: data, analysis and evaluation models, used in clinical trials with pre-defined patient subgroups. The chapter discusses an important component of any clinical trial optimization exercise, namely, sensitivity assessments aimed at "stress-testing" an optimal analysis model based on the optimal multiplicity adjustment. It also presents a detailed overview of an optimization exercise aimed at identifying an analysis model with an optimal multiplicity adjustment in a multi-population clinical trial. The chapter deals with optimization considerations in a multi-population clinical trial with a single pre-defined subpopulation. It also discusses optimality considerations in a multi-population Phase III clinical trial with three potential regulatory claims: broad, restricted and enhanced claims. The chapter focuses on the problem of optimal selection of the parameters of the decision rules such as influence and interaction thresholds used in multi-population clinical trials.
