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Lilly Q. Yue

U.S. Food and Drug Administration



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Heng Li

U.S. Food and Drug Administration



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473 – Subgroups Analyses: Planned Versus Ad-Hoc: How Many Are Too Many?

Subgroup Analysis in Regulatory Decision Making

Sponsor: Biopharmaceutical Section
Keywords: subgroup analysis, interpretation and reporting, biomarker, regulatory decision making

Lilly Q. Yue

U.S. Food and Drug Administration

Heng Li

U.S. Food and Drug Administration

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.

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