ABSTRACT
This chapter presents applications of the Clinical Scenario Evaluation (CSE) approach to a general setting for Go/No-Go (GNG) decision making and determination of probability of success in the early phase of clinical development. It introduces the key components of the CSE approach, that is, data, analysis and evaluation models, used during early phase of clinical development in the context of GNG decision and probability of success evaluation. The chapter also introduces a proof-of-concept (POC) trial and illustrates the operating characteristics of an analysis model based on a traditional hypothesis testing approach in a GNG setting. The chapter discusses a general Bayesian framework for the GNG decision-making process. This framework applies to one set of criteria based on a target product profile (TPP) with two levels of efficacy-informing decision making and mitigates the inability of the traditional frequentist strategies to inform the TPP.
