Randomized reverse marker strategy design for prospective biomarker validation
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چکیده
منابع مشابه
Randomized reverse marker strategy design for prospective biomarker validation
We describe a novel study design for validating marker-based treatment strategies meant to select among possible therapeutic options using a biologic marker. Studying existing designs in realistic scenarios, we demonstrate that this design is more than four times more efficient for testing the interaction between a marker and its intended treatment. Our analysis employs a simple parametric fram...
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The role of cetuximab in the treatment of advanced non-small cell lung cancer (NSCLC) is currently unclear. The molecular target of cetuximab, epidermal growth factor receptor (EGFR), as measured by FISH, has shown potential as a predictive biomarker for cetuximab efficacy in NSCLC. SWOG S0819 is a phase III trial evaluating both the value of cetuximab in this setting and EGFR FISH as a predict...
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متن کاملTitle: Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819 Authors and Affiliations:
Running Title: On the design of SWOG S0819
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ژورنال
عنوان ژورنال: Statistics in Medicine
سال: 2014
ISSN: 0277-6715,1097-0258
DOI: 10.1002/sim.6146