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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 #318404 View Presentation
Title: Adaptive Enrichment Trials for Biomarker-Guided Treatments
Author(s): Noah Simon* and Richard Macey Simon
Companies: University of Washington and National Cancer Institute
Keywords: adaptive ; enrichment ; biomarker

In this talk we will discuss a class of adaptive enrichment designs: clinical trial designs that allow the simultaneous construction and use of a biomarker, during an ongoing trial, to adaptively enrich the enrolled population. For poorly characterized biomarkers, these trials can significantly improve power while still controlling type one error. However there are additional challenges in this framework: How do we adapt our enrollment criteria in an "optimal" way? (what are we trying to optimize for?) How do we run a formal statistical test after updating our enrollment criteria? How do we estimate an unbiased treatment effect-size in our "selected population"? (combatting a potential selection bias) In this talk we will give an overview of a class of clinical trial designs and tools that address these questions.

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

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