Study Designs for Prognostic Marker Validation
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*Pennello Gene, CDRH  Rong Tang, Food and Drug Administration 

Keywords: study design, prospective-retrospective design, case-cohort, nested case control, prognostic marker

For validation of prognostic markers, the prospective-retrospective design enjoys popular support in the research literature and in regulatory submissions. In this talk, we will also look at alternative study designs, such case-cohort and nested case-control designs, particularly in situations where disease prevalence is low or it is too costly to obtain marker status from a very large retrospective cohort.