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Key Subgroup Analysis Issues in Clinical Trials

Track:
Statistical Science and Quantitative Thinking

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
299C

Room Number:
5B

Level:
Intermediate

Type:
Session

Title:
Key Subgroup Analysis Issues in Clinical Trials

Chair(s):
Joachim Vollmar
Executive Consultant
International Clinical Development Consultants LLC, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
The New CHMP Guideline on Subgroup Analysis: What's New?
David Ohlssen, PhD
Senior Expert Methodologist
Novartis Pharmaceuticals Corporation, United States

FDA Perspective
Lilly Yue, PhD
Deputy Director, Division of Biostatistics, CDRH/FDA
FDA, United States

Key Statistical Considerations in Subgroup Analysis
Ilya Lipkovich, PhD
Senior Director, Center for Statistics in Drug Development, Innovation
Quintiles Inc., United States