Measures for Conducting Comparative Benefit: Risk Assessment

In this article, we review quantitative measures that have been proposed to conduct comparative benefit:risk assessment. Comparative benefit:risk assessment could be conducted at the societal level (recommending drug approval or the adoption of a medical policy) or at the individual level (making a treatment selection). Benefit:risk assessment involves balancing between benefit and risk. The need to make decisions based on all information forces us to think diligently on the trade-off between benefit and risk in a structured manner. Even though we discuss measures to facilitate benefit:risk assessment in this article, we want to remind the readers that it cannot replace the rigorous assessment of efficacy and safety individually. Rather, it complements the traditionally separate safety and efficacy analysis by bringing safety and efficacy assessment together in a unified approach.