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Key Subgroup Analysis Issues in Clinical Trials
Session Chair(s)
Joachim Vollmar, MSC
Executive Consultant, International Clinical Development Consultants LLC (ICDC), United States
This session will discuss key subgroup analysis issues arising in late-phase clinical trials, including statistical methods commonly used in exploratory and confirmatory subgroup analysis and applicable regulatory requirements.
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)
David Ohlssen, PHD
Senior Expert Methodologist, Novartis Pharmaceuticals Corporation, United States
The New CHMP Guideline on Subgroup Analysis: What's New?
Lilly Yue, PHD
Deputy Director, Division of Biostatistics, CDRH/FDA, U.S. FDA, United States
FDA Perspective
Ilya Lipkovich, PHD
Senior Director, Center for Statistics in Drug Development, Innovation, IQVIA, United States
Key Statistical Considerations in Subgroup Analysis
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