Risk Stratification Markers in Clinical Practice: An FDA Perspective

• Activity Number: 602
• Type: Invited
• Date/Time: Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Section on Statistics in Epidemiology
• Author(s): Estelle Russek-Cohen*+
• Companies: FDA
• Keywords: Absolute risk ; Longitudinal studies ; In VItro Diagnostic Devices

Abstract

Risk stratification markers assist physicians in identifying patients that are at higher risk for developing a disease such as a particular form of cancer, cardiovascular disease or a stroke. FDA regulates medical devices that are intended to help physicians stratify patients into high or low risk groups with respect to developing a particular disease. Devices may combine the results of one or more in vitro assays along with demographic features, whereas others have used features extracted off imaging systems rather than in vitro assays. I will discuss some of the study designs and data analysis issues in the context of validating an intended use of risk stratification and some of the challenges sponsors may face if they wish to bring such a product to market.