TL10: Evaluation of the Risk Prediction Performance of Biomarkers and Tests
*Yuying Jin, FDA/CDRH 


There are increasing interests in assessing the risk prediction performance of noval biomarkers and tests. The related clinical practices include quantifying the cardiovascular disease risk, predicting cancer recurrence, etc. In order to evaluate the risk, it is crucial to have an appropriate study design, an representative risk population and utilize proper statistical methodologies. During this roundtable, participants can share their experience in designing a clinical study for risk assessment. Furthermore, participants can discusss current statistical methods/models for evaluating the performance.