DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-673-L04-P; CME 1.00; RN 1.00

Alternative methods to a frequentist approach, such as Bayesian, may be superior in certain situations; particularly, when analyzing trial data to support approvals in small populations. Regulators are increasingly considering novel methods.

Learning Objectives

Examine global considerations for leveraging Bayesian approaches in pivotal trials to support marketing authorization; State and debate the situations and circumstances where the Bayesian approach may be the most appropriate method of analysis; Discuss health authority considerations that could facilitate the use of alternative analytical methods beyond the frequentist approach; Identify ways to bridge existing gaps in applying Bayesian methods in clinical research.

Chair

Philip Hougaard, DrSc, PhD

Speaker

FDA perspective
Yun Wang, PhD

EMA Perspective
Andrew Thomson, PhD, MA, MS

Industry Perspective
Scott Berry, PhD