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Abstract Details
Activity Number:
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485
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Type:
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Invited
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Date/Time:
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Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Statistics in Biopharmaceutical Research Journal
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Abstract - #300018 |
Title:
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Genomic Classifier for Patient Enrichment: Misclassification and Type I Error Issues in Pharmacogenomics Noninferiority Trial
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Author(s):
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Sue-Jane Wang*+
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Companies:
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U.S. Food and Drug Administration/CDER
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Address:
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Office of Biostatistics, Silver Spring, MD, 20993,
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Keywords:
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Biomarker Qualification ;
Disease prevalence ;
False positive classification ;
Nondifferential misclassification ;
noninferiority ;
positive predictive value
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Abstract:
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Unlike the phenotypic characteristics, a genomic diagnostic assay is needed to assess whether a patient truly has the genomic characteristics of interest for therapeutic investigation. However, in reality, the diagnostic assay is not perfect without misclassification error. We consider a targeted or enrichment pharmacogenomics clinical trial with a non-inferiority objective. In this paper presentation, we assess the maximum type I error rate associated with falsely concluding non-inferiority in the presence of misclassification of subject's genomic status. To achieve a prescribed level of positive predictive value, the feasibility of a genomic biomarker for enrichment in a non-inferiority study is a function of disease prevalence. If the evidential standard of much less inflation of type I error rate can be achieved, a genomic biomarker, if qualified, may be useful as an adjunct tool for patient selection.
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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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