Study Designs for Prognostic Marker Validation
View Presentation *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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC