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Activity Number: 474
Type: Invited
Date/Time: Wednesday, August 3, 2016 : 8:30 AM to 10:20 AM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #317999 View Presentation
Title: Estimation After Adaptive Population Enrichment Design
Author(s): Vlad Dragalin*
Companies: Janssen
Keywords: adaptive design ; population enrichment ; multiple comparisons ; subgroup selection ; estimation after adaptive design ; stratified medicine

Population enrichment strategies offer a specific adaptive design methodology to study the effect of experimental treatments in various sub-populations of patients under investigation. Instead of limiting the enrollment only to the enriched population, these designs enable the data-driven selection of one or more pre-specified subpopulations at an interim analysis and the confirmatory proof of efficacy in the selected subset at the end of the trial. In this presentation, the general hypothesis testing methodology and designing issues when planning such a design will be reviewed but the focus will be on the estimation of treatment effects after such adaptive tests.

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

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