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Activity Number:
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410
- Diagnostic Tests: Regulatory Considerations of Intermediate Outputs and Oncology Screening, and Optimal Point of Heterogeneous ROC Curves
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Type:
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Contributed
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Date/Time:
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Tuesday, July 30, 2019 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Medical Devices and Diagnostics
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Abstract #301827
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Presentation
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Title:
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Statistical Methods to Address Verification Bias for Evaluating Screening Tests
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Author(s):
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Changhong Song*
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Companies:
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FDA
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Keywords:
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screening;
diagnostics;
verificaiton bias
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Abstract:
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The objectives of many clinical studies are to evaluate screening devices. For this type of studies, there can be a lot of statistical issues and challenges. For example, the clinical truth (i.e. whether a subject is truly positive for a specific cancer type) may not be available for all subjects or only a small subset of subjects can have clinical truth. This study reviews common study designs and statistical analysis methods to address verification bias for evaluating screening tests.
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Authors who are presenting talks have a * after their name.
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