FDA 贝叶斯方法临床试验草案指南解读会：设计、分析与审评考量（2026年10月14日）

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News & Events for Human Drugs

Virtual | Virtual

Event Title

Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations

October 14, 2026

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News & Events for Human Drugs

About this Event (Hosted by CDER SBIA)

In January 2026, the Agency published the draft guidance “Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products” to address a PDUFA VII commitment. The guidance discusses important considerations such as success criteria and operating characteristics, the use of external information in a prior distribution, estimands and missing data in a Bayesian setting, software and computation, and how to document and report Bayesian analyses.

**This event begins with a required, pre-recorded video that you can complete at your own pace prior to the live panel discussion.**The recording will present an overview of the considerations within the guidance and their implications on the design of clinical trials using Bayesian methods.

On-Demand Video – Please View Before Panel Discussion

Video 1

Intended Audience

Clinical trial, regulatory science and regulatory affairs professionals working on clinical trials and studies where Bayesian approaches may be used or potentially beneficial. Bayesian methods can potentially be used as an alternative statistical approach and are most beneficial in settings where it is appropriate to leverage information from previous studies or use adaptive designs. The most common settings include pediatric and rare disease trials.

Topics Covered

A brief introduction to Bayesian approaches
Success criteria and operating characteristics in Bayesian trials
Considerations for prior distributions
Additional topics including missing data and estimands, software usage, documenting and reporting expectations for Bayesian analyses
Descriptions of specific settings where Bayesian methods have been previously used.

Presentation:Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations

John Scott, PhD
Director
Division of Biostatistics | Office of Biostatistics and Pharmacovigilance | CBER | FDA

James Travis, PhD
Master Mathematical Statistician
Division of Biometrics II (DBII) | Office of Biostatistics (OB)
Office of Translational Science (OTS) | CDER | FDA

Van Tran, PhD
Senior Mathematical Statistician
Division of Biometrics VII | OB | OTS | CDER | FDA

Panelists:

Mark Rothmann, PhD
Division Director
DBII | OB | OTS | CDER | FDA

John Alexander, MD, MPH
Deputy Director
Division of Pediatric and Maternal Health | Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine | Office of New Drugs | CDER | FDA

Continuing Education (CE)

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

RAPSas eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
SOCRAwho accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
SQAas eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
ACRPfor continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

Resources

FDA draft guidance Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
Content current as of:

08/24/2026 *

Regulated Product(s)

*   Drugs

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