325 – Regulatory Review Issues for Medical Devices and Diagnostics
Statistical Issues Associated with Prognostic Biomarker Evaluation
Kyunghee Song
FDA/CDRH
In general, the evaluation of diagnostic test using biomarkers with prognostic claim should include the clinical outcome studies. The clinical outcomes are observed in a follow-up fashion and the clinical performance to support the clinical utility of the device depends on the analysis of these clinical outcomes. However, before making any clinical interpretation, it should be noted that the determination of the biomarker status depends on the diagnostic tests, and there are likely to be false positives and false negatives when imperfect diagnostic tests are used. Therefore, analyzing and interpreting the survival outcomes without considering this possibility introduce bias in the clinical outcome study. In this talk, I will conduct a series of simulation study to address these issues and also discuss some regulatory concerns.
