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.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.