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Activity Number: 410 - Diagnostic Tests: Regulatory Considerations of Intermediate Outputs and Oncology Screening, and Optimal Point of Heterogeneous ROC Curves
Type: Contributed
Date/Time: Tuesday, July 30, 2019 : 2:00 PM to 3:50 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #301827 Presentation
Title: Statistical Methods to Address Verification Bias for Evaluating Screening Tests
Author(s): Changhong Song*
Companies: FDA
Keywords: screening; diagnostics; verificaiton bias

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.

Authors who are presenting talks have a * after their name.

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