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Abstract:
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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 presentation, we describe a case study for the development and implementation of a structured B-R framework in the vorapaxar TRA-2P TIMI 50 study, along with key considerations that went into the evaluation.
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