ABSTRACT
The benefits of a medicine can only be understood in the context of the risks or harms associated with that medicine, and vice versa. In recent years, health authorities and industry-wide working groups have actively pursued structured benefit–risk (B–R) assessment efforts. Despite these efforts, a paucity of published B–R case studies that utilized a structured B–R framework remains. In this chapter, we describe a case study for the development and implementation of a structured B–R framework in the vorapaxar TRA-2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) study, along with key considerations that went into the evaluation.
