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Opportunities to use Bayesian approaches and regulatory experience

Presented During: PS45: Squeezing More Juice from Patient Data: Enhancing Decision-Making in Adaptive Trials by Using Early Endpoint Data

Conference: ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2025

09/26/2025: 1:30 PM EDT - 2:45 PM EDT
Parallel

Description

In this session, we will discuss lessons learned on the use of Bayesian approaches by presenting examples in which an early endpoint predicts later outcomes at an interim analysis and when strength is borrowed to empower a clinical trial for pediatrics. The FDA guidance on the use of Bayesian statistics for medical devices will clarify the regulatory perspective on these examples.

Keywords

FDA

Bayesian

Longitudinal Data

Regulatory Perspective

Borrowing

CDRH

Presenting Author

Telba Irony, Johnson & Johnson