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Beyond the Frequentist Approach in Hard to Recruit Populations: Acceptance of Bayesian Methods for Registration/Pivotal Trial
Session Chair(s)
Philip Hougaard, DrSc, PhD
Vice President, Biostatistics and Data Science
Lundbeck A/S, Denmark
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 Objective : Examine global considerations for leveraging Bayesian approaches in pivotal trials to support marketing authorization; 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.
Speaker(s)
FDA Perspective
Representative Invited
FDA, United States
EMA Perspective
Representative Invited
European Medicines Agency, Netherlands
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