Current Assessment of Risk–Benefit by Regulators: Is It Time to Introduce Decision Analyses?

摘要: Regulatory risk-benefit assessments may overweight small but serious risks relative to benefits. Using terfenadine and torsade de pointes as an exemplar, we illustrate how a different decision result when outcomes are assessed using quality-adjusted life-years within decision-analytical framework. The adoption of common measures health outcome the use analyses, which will allow uncertainty be characterized evidence compiled from disparate sources, inform complex decisions should used in conjunction with qualitative assessments.