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Activity Number: 164
Type: Topic Contributed
Date/Time: Monday, August 10, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #315465 View Presentation
Title: Subgroup Analysis: Issues in FDA-Reviewed Clinical Trials
Author(s): Kathleen Fritsch*
Companies: FDA
Keywords: subgroups
Abstract:

This talk will discuss various FDA guidances on subgroup analyses (typically referring to gender, race, and age in various contexts), and how these analyses and other subgroup analyses of interest are typically addressed in a statistical review for an NDA or BLA. This talk will also consider issues that arise when designing studies with the potential for a targeted subgroup claim.

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

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