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Abstract Details
Activity Number:
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161
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #305623 |
Title:
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Testing for Efficacy in Multiple Genetic Subgroups
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Author(s):
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Szu-Yu Tang*+ and Jason Hsu
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Companies:
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The Ohio State University and The Ohio State University
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Address:
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2650 Neil Ave. Apt. 102, Columbus, OH, 43202, United States
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Keywords:
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multiple testing ;
partition testing ;
subgroup analysis
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Abstract:
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Traditionally, clinical studies aim to prove drug efficacy over broad patient populations. However, in addition to testing for broad efficacy, there may be reason to test for efficacy in one or more genetic subgroups. For example, the recently FDA approved drug Xalkori for non-small cell lung cancer might benefit patients with ALK mutation more. As another example, mutations in P450 metabolizer genes such as 2C19 and 2D6 might affect efficacy of some drugs. We show partition testing simplifies the formulation of multiple testing for such studies by recognizing logical relationship between the parameters, minimizing the number of hypotheses to be tested. In addition, pivoting the partition test provides a solution to the consistency problem in subgroup analysis.
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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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