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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)
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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