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
Full text not available from this repository.Abstract
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: | http://dij.sagepub.com/ |
| 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: | 07 Jan 2024 02:03 |
| URI: | http://eprints.lse.ac.uk/id/eprint/64648 |
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