This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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150
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Type:
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Invited
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Date/Time:
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Monday, August 2, 2010 : 10:30 AM to 12:20 PM
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Sponsor:
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Biometrics Section
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| Abstract - #305930 |
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Title:
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Clinical Trial Designs for Predictive Biomarker Validation: Theoretical Considerations and Practical Challenges
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Author(s):
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Daniel Sargent*+ and Sumithra Mandrekar
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Companies:
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Mayo Clinic and Mayo Clinic
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Address:
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Harwick 8-27, 200 1st St SW, Rochester, MN, 55905, USA
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Keywords:
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Biomarker ;
Clinical Trial ;
Retrospective Study ;
Cancer
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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 featuress of these various biomaker validation strategies in the context of real trials.
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