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Activity Number:
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194
- Topics in Clinical Trials - I
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Type:
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Contributed
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Date/Time:
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Tuesday, August 4, 2020 : 10:00 AM to 2:00 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313535
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Title:
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A Two-Stage Stratified Clinical Trial Design with Survival Outcomes and Adjustment for Misclassification in Predictive Biomarkers
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Author(s):
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Shou-En Lu* and Yanping Chen and Yong Lin and Weichung Joe Shih and Hui Quan
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Companies:
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Rutgers School of Public Health and Rutgers School of Public Health and Rutgers School of Public Health and Rutgers School of Public Health and Sanofi
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Keywords:
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group sequential design;
predictive biomarker;
missclassification
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Abstract:
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In this paper, we consider a two-stage stratified clinical trial design by predictive biomarkers, with survival outcomes, where the marker assay and the classification rule are possibly subject to error. We consider the composite hypothesis involving testing the treatment effect in the overall population as well as the treatment effect in the biomarker positive population. We derive the sequential tests for the composite hypothesis as well as the component tests for the overall population and the marker-positive population, with an adjustment for the misclassification of predictive biomarker(s). We discuss the power analysis with the control of the type-I error rate and show the adverse impact of the misclassification on the power. We illustrate our method with an example of a recently successful development of immunotherapy in non-small-cell lung cancer.
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Authors who are presenting talks have a * after their name.
