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Design and Sample Size Planning for Multiregional Clinical Trials
Session Chair(s)
Yeh-Fong Chen, PhD
Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
United States
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 : 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.
Speaker(s)
Statistical Considerations in Planning Sample Size for MRCT
H. M. James Hung, PhD
FDA, United States
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
Optimal Designs for Multiregional Clinical Trials with an Additional Regional Requirement
Zhaoyang Teng, MA
Boston University, United States
PhD Candidate, Biostatistics
Discussion from Industry Perspective
Gordon Lan, PhD
Janssen R&D, LLC, United States
Senior Scientific Director
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