ABSTRACT
We use the terms benefits and risk to describe the effects of medical interventions. More correctly, they are potential benefits and potential harms, because medicine can potentially change people’s lives for better or worse. For any given individual, we do not know what the specific outcomes will be. The goal for individuals and organizations that develop, approve, prescribe, and market drugs, biologics, vaccines, and devices is to maximize the probability that the user will enjoy meaningful benefits without sustaining undue harm. Systematically assessing benefit-risk (B-R) provides a means for defining this goal and measuring the effects of treatment choices against it.
