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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, Food and Drug Administration, 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)
H. M. James Hung, PHD
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER, FDA, United States
Statistical Considerations in Planning Sample Size for MRCT
Zhaoyang Teng, MA
PhD Candidate, Biostatistics, Boston University, United States
Optimal Designs for Multiregional Clinical Trials with an Additional Regional Requirement
Gordon Lan, PHD
Senior Scientific Director, Janssen R&D, LLC, United States
Discussion from Industry Perspective
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