Thinking Of Clinical Development From A Bayesian Lens

By Esha Senchaudhuri, Cytel

Program and portfolio optimization creates a framework throughout the course of the clinical development journey, that enables trial sponsors to make decisions about when to continue a clinical trial. A critical factor in the ability to optimize clinical development at this high level requires the construction of decision rules that clinical trial sponsors can use to determine whether a trial should proceed from Proof of Concept to Phase 2b, and from Phase 2b to Phase 3.

According to a recent article by Cytel co-founder Nitin Patel and Chief Scientific Officer Yannis Jemiai, a key factor in the construction of such decision rules is the ability to ‘explicitly model the relationship between trial designs and performance criteria.’ [1] Their paper, a part of an award-winning book Bayesian Methods in Pharmaceutical Research, offers an overview of where Bayesian methods should be injected into the process of optimization at the program and portfolio level.