There is a rapid growth in identifying advanced biomarkers which enable the use of biomarker in guiding therapy, predicting treatment response, predicting disease recurrence and progression. It becomes more common that clinical validation study for the novel biomarkers involves time-event data.

In this presentation, regulatory perspective will be shared for the clinical validation of biomarkers with a focus of prognostic and risk prediction biomarkers. We will discuss potential performance measures to assess the biomarker performance that can accommodate the time-varying nature of the clinical study. The study design and common issues related to statistical analyses will be also discussed.