A Frequentist Decision-Making Framework

In this chapter, we review the Frequentist approach to hypothesis testing and in particular the two-action decision problem. The Frequentist approach to statistical inference involves examining probability via its long-run frequency interpretation. Procedures for assessing evidence and making decisions under the Frequentist approach are calibrated by how they would perform when they are used repeatedly. In the context of drug development, the two actions correspond to progressing or not progressing a drug for further development. These two actions are fundamental to decision-making in drug development.