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Refining the Benefit–Risk Framework for the Assessment of Medicines: Valuing and Weighting Benefit and Risk Parameters
Author(s) -
Walker S,
Liberti L,
McAuslane N
Publication year - 2011
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2010.290
Subject(s) - weighting , product (mathematics) , stakeholder , risk analysis (engineering) , clinical pharmacology , computer science , management science , medicine , pharmacology , engineering , mathematics , economics , geometry , management , radiology
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. Clinical Pharmacology & Therapeutics (2011) 89 2, 179–182. doi: 10.1038/clpt.2010.290