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Session Chair(s)
Joachim Vollmar, MSC
Executive Consultant
International Clinical Development Consultants LLC (ICDC), United States
Learning Objective : Identify commonly used exploratory and confirmatory subgroup analysis methods; Define statistical methods used for addressing multiplicity in clinical trials with pre-specified subgroups; Identify the factors that influence the selection of data mining methods used in exploratory subgroup analysis; Discuss key regulatory requirements in subgroup analysis.
Speaker(s)
The New CHMP Guideline on Subgroup Analysis: What's New?
David Ohlssen, PHD
Novartis Pharmaceuticals Corporation, United States
Senior Expert Methodologist
FDA Perspective
Lilly Yue, PHD
U.S. FDA, United States
Deputy Director, Division of Biostatistics, CDRH/FDA
Key Statistical Considerations in Subgroup Analysis
Ilya Lipkovich, PHD
IQVIA, United States
Senior Director, Center for Statistics in Drug Development, Innovation
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