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Activity Number: 473
Type: Invited
Date/Time: Wednesday, August 3, 2016 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #318100 View Presentation
Title: Subgroup Analysis in Regulatory Decision Making
Author(s): Lilly Yue*
Companies: FDA/CDRH/OSB
Keywords: subgroup analysis ; interpretation and reporting ; biomarker ; regulatory decision making
Abstract:

This presentation discusses regulatory and statistical issues with subgroup analysis in regulatory decision making, for medical products ranging from therapeutic treatments to companion diagnostics. Such issues include interpretation and reporting of completed clinical trials and design of new studies where subgroup differences are expected.


Authors who are presenting talks have a * after their name.

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