This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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238
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Type:
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Contributed
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Date/Time:
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Monday, August 2, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #307286 |
Title:
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Detecting a Cutoff Point for Predictive Biomarkers in Clinical Trials Using Contrast Tests
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Author(s):
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Jianliang Zhang*+
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Companies:
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MedImmune
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Address:
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One Medimmune Way, Gaithersburg, MD, 20878, USA
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Keywords:
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predictive biomarker ;
contrast test
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Abstract:
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Predictive biomarkers are used to identify patients who are likely or unlikely to benefit from a specific therapy. The biomarker is usually based on a measurement involving a single gene or protein, or a combination of many variables. A cutoff point in the measurement to categorize patients according to their likelihood of benefiting from the therapy needs to be established in early phase drug development. Such predictive biomarker information will then be used and confirmed in late phase clinical development. A statistical approach using contrast tests for determining such a cutoff is developed in this presentation. The method is expanded to various types of endpoints with power and sample size calculations as well.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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