Refining the Benefit–Risk Framework for the Assessment of Medicines: Valuing and Weighting Benefit and Risk Parameters

This is the authors' abstract. We don't add key points for this paper.

A common framework is necessary for the transparent articulation of the benefits and risks of a therapeutic product across disparate stakeholders. The assignment of value and weighting to each component parameter presents challenges deriving from different stakeholder objectives, methods, and perspectives. Building on prior experiences with a validated framework approach, this forum focused on identifying challenges and approaches to the assignment of values and weightings using a case study applied to a hypothetical medicinal product.