Keywords: Benefit, Harm, Risk, Patient Input
In this talk we discuss important factors used in benefit risk determinations for the regulation of medical products and briefly provide examples to illustrate how to weigh these factors. A ground-breaking factor 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.