Benefit-Risk Determinations at the FDA-Center for Devices and Radiological Health

• Activity Number: 620
• Type: Invited
• Date/Time: Thursday, August 13, 2015 : 8:30 AM to 10:20 AM
• Sponsor: ENAR
• Author(s): Telba Irony* and Martin Ho
• Companies: FDA and FDA/CDRH
• Keywords: Benefit ; Risk ; Regulatory Decisions ; Patient Preferences ; Uncertainty ; Decison Analysis

Abstract

On March 2012, the Center for Devices and Radiological Health at the FDA issued a guidance document listing the factors to be considered when the Center makes Benefit - Risk determinations in premarket reviews. In this presentation we will discuss these factors and briefly provide an example to illustrate how mathematical decision analysis can be used to weigh these factors in order to reach a postmarket regulatory decision. A ground-breaking factor described in the guidance is "patient tolerance for risk and perspective on benefit". Until now, this factor has not been formally considered in the regulatory setting. Through an example, we will demonstrate how to obtain quantitative evidence on how patients weigh benefits against risks and how this evidence could be used in the regulatory setting.