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Design and Sample Size Planning for Multiregional Clinical Trials

Track:
Statistical Science and Quantitative Thinking

Day & Time:
June 16, 8:30AM - 10:00AM (Pacific Standard Time)

Session Number:
118

Room Number:
5B

Level:
Intermediate

Type:
Session

Title:
Design and Sample Size Planning for Multiregional Clinical Trials

Chair(s):
Yeh-Fong Chen, PhD
Mathematical Statistician, Office of Translational Sciences, CDER
FDA, United States

Description:
This session will address how to design a multiregional clinical trial depending on the availability of associated historical information, and will include regulatory and industry perspectives.

Learning Objective(s):
Articulate potential issues in designing a multiregional clinical trial; Devise solutions applicable to sample size planning for trials with potential inhomogeneous treatment effects across regions.

Presentation(s) & Speaker(s):
Statistical Considerations in Planning Sample Size for MRCT
H. M. James Hung, PhD
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
FDA, United States

Optimal Designs for Multiregional Clinical Trials with an Additional Regional Requirement
Zhaoyang Teng, MA
PhD Candidate, Biostatistics
Boston University, United States

Discussion from Industry Perspective
Gordon Lan, PhD
Senior Scientific Director
Janssen R&D, LLC, United States