ABSTRACT
Decision analysis is a quantitative approach to making optimal decisions. It is generally valuable in drug development, but may be of particular value for platform trials, where it might not only improve decision quality but also communication among stakeholders. In this technique, a quantitative utility function is created to represent the value of particular outcomes. The overall expected value of the strategy is then simply the sum of the utility values of the outcomes, each weighted by its probability of occurrence given the strategy. In this chapter, we give three examples of decision analysis; optimizing the size of a proof of concept trial, optimizing the development path after a biomarker stratified Phase 2 study, and optimizing a Phase 3 study design in the presence of a still uncertain biomarker hypothesis. In the latter case, different utility functions representing perspectives of multiple stakeholders are used, illuminating possible areas of misalignment among stakeholders. Finally, the application of these techniques to platform trials themselves is discussed.
