ABSTRACT
In Chapters 2–8, the decision-making in the clinical trials has been restricted to a single criterion, either statistical significance or a Bayesian posterior probability. It has recently been argued that such simple criteria are inappropriate for making GO/NOGO decisions in proof-of-concept trials. In this chapter, we look at the use of dual criteria in making these decisions. This extension to dual criteria requires a corresponding extension of our previous results. In this chapter, we generalise the concept of assurance to calculate the unconditional probabilities of GO, NOGO and PAUSE, the latter occurring when one criterion is not met. We show how prior bounds have a role to play in this extend case and cover conditional posterior distributions as well. We also cover Bayesian counterparts to these extend approaches.
