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Structured approaches to benefit-risk assessment: a case study and the patient perspective

Levitan, Bennett, Phillips, Lawrence D. and Walker, Stuart (2014) Structured approaches to benefit-risk assessment: a case study and the patient perspective. Therapeutic Innovation and Regulatory Science, 48 (5). pp. 564-573. ISSN 2168-4790

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Identification Number: 10.1177/2168479014536500


Assessing the utility of structured approaches to benefit-risk assessment of medicinal products is challenging, in part due to the lack of a gold standard for results and the uncertainty inherent in the data. In place of conducting formal testing, obtaining feedback from users of structured approaches provides insight into their value and limitations. The authors conducted a simulated single-session benefit-risk decision in which 3 groups applied the PhRMA BRAT(Pharmaceutical Research and Manufacturers of America Benefit-Risk Action Team) framework or the multicriteria decision analysis approach. The groups were provided with background and data for a hypothetical triptan for acute migraine in a population with cardiovascular risk factors and were asked to determine and defend an approval decision. Three insights emerged consistently from the groups: (1) the value of a structured approach to benefit-risk assessment, (2) the clarity provided by real-time visualization tools, and, most critically, (3) the importance of bringing the patient into the discussion early.

Item Type: Article
Official URL:
Additional Information: © 2014 The Authors.
Divisions: Management
Subjects: H Social Sciences > HD Industries. Land use. Labor > HD61 Risk Management
R Medicine > RS Pharmacy and materia medica
R Medicine > RZ Other systems of medicine
Date Deposited: 10 Dec 2015 13:09
Last Modified: 20 Oct 2021 00:49

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