Refining the benefit-risk framework for the assessment of medicines: valuing and weighting benefit and risk parameters.
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.
CMR International Institute for Regulatory Science, London, UK.
S
S
Walker
L
L
Liberti
N
N
McAuslane
B S
BS
Levitan
D004358:Drug Therapy; D004335:Drug and Narcotic Control; D006801:Humans; D018570:Risk Assessment