Abstract Details
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Activity Number:
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632
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 7, 2014 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #311223
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View Presentation
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Title:
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Biomarker-Based Clinical Trials: an Overview
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Author(s):
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Daniel Sargent and William Barry*+
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Companies:
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Mayo Clinic and Dana-Farber Cancer Institute
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Keywords:
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Biomarker ;
Phase III Clinical Trial ;
Adaptive Design
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Abstract:
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Biomarkers can add value to current practice by guiding patient- specific treatment selection. Well designed retrospective analysis from prospective RCT can quickly forward effective treatments to marker defined patient subgroups (e.g. K-RAS and colorectal cancer). Enrichment designs are appropriate when preliminary evidence suggest that patients with/without that marker profile do not benefit from treatments in question; however this may leave questions unanswered (e.g. Herceptin and breast cancer). An unselected design is optimal where preliminary evidence regarding treatment benefit and assay reproducibility is uncertain. Adaptive analysis designs allow for pre-specified marker defined subgroup analyses of data from a RCT. We discuss features of these various biomarker validation strategies in the context of real trials.
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Authors who are presenting talks have a * after their name.
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