ABSTRACT
This chapter investigates Clinical Scenario Evaluation (CSE)-based approaches to systematic and quantitative evaluation of candidate multiplicity adjustment strategies in traditional and advanced settings. It discusses the general CSE framework in the context of trials with multiple clinical objectives. The chapter provides an overview of key CSE considerations followed by case studies that focus on optimization problems arising in trials with several dose-placebo comparisons and clinical endpoints. It includes R code based on the Mediana package at the end of each case study to provide software implementation of CSE-based assessments. The chapter illustrates the use of sensitivity assessments to select the optimal analysis model which is robust with respect to deviations from the main data model assumed in the rheumatoid arthritis clinical trial. It provides a summary of additional sensitivity assessments. This sensitivity assessment approach will focus on evaluating the characteristics of the two multiple testing procedures under quantitative deviations from the main data model using random perturbations.
