ABSTRACT
This introduction presents an overview of the key concepts discussed in the subsequent chapters of this book. The book explores the connections between Clinical Scenario Evaluation (CSE) and clinical trial optimization. It presents a more comprehensive review of optimization algorithms and sensitivity assessments aimed at selecting the best-performing multiplicity adjustment procedure in a similar setting of a multi-population clinical trial. The book provides a survey of CSE-based approaches to identifying best-performing analysis strategies and decision rules in clinical trials. It illustrates the process of setting up a CSE framework and defining its components in real clinical trials using an R package that was designed to support CSE in clinical trial applications. The book also provides an overview of popular approaches to defining optimization algorithms in clinical trials, including direct optimization and tradeoff-based optimization strategies. It further provides an overview of easy-to-implement sensitivity assessments that are incorporated into the general clinical trial optimization framework.
