Perspectives on the Use of a Bayesian Approach in Designing Seamless Phase 2/3 Clinical Trials with Dose Selection, Early Stopping for Futility and Efficacy, or Sample Size Re-estimation.

Natalia Muehlemann¹, Jan Priel², Marc Vandemeulebroecke³, David Ohlssen⁴, Yun Wang⁵, Alexei Ionan⁵

¹Curie.Bio, Cambridge, MA, USA. natasha@curie.bio.

²Cytel Inc., Cambridge, MA, USA.

³Statistical Innovation, Bayer BCC, Basel, Switzerland.

⁴Advanced Quantitative Science, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

⁵Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, MD, USA.

PubMed DOI

Abstract

Seamless Phase 2/3 clinical trial designs have become an increasingly attractive strategy to improve development efficiency by reducing the time between development phases and enabling the reuse of early-stage data in confirmatory analyses. In parallel, Bayesian methods have gained attention for their ability to support adaptive decision-making under uncertainty, particularly in complex trial desi…

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