Pragmatic Multicriteria Decision Analysis (MCDA) Combined With Advanced Pharmacoepidemiology for Benefit-Risk Assessments of Medicines Adapted to the Real-Life Constraints of Regulators: Development and Case Study

Author:

Goetghebeur Mireille M.,Wagner Monika,Nikodem Mateusz,Zyla Agnieszka,Micaleff Alain,Amzal Billy

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference38 articles.

1. Dolan JG.Multi-criteria clinical decision support. A primer on the use of multiple-criteria decision-making methods to promote evidence-based, patient-centered healthcare. Patient. 2010;3:229–248.

2. Baltussen R, Stolk E, Chisholm D, Aikins M. Towards a multi-criteria approach for priority setting: an application to Ghana. Health Econ. 2006;15:689–696.

3. Leong J, McAuslane N, Walker S, Salek S. Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives. Pharmacoepidemiol Drug Saf. 2013;22:1004–1012.

4. Hughes D, Waddington EAJ, Mt-Isa S, Goginsky A, Chan E, Downey G. Recommendations report. Recommendations for the methodology and visualisation techniques to be used in the assessment of benefit and risk of medicines. IMI-PROTECT Benefit-Risk Group. http://www.imi-protect.eu/benefit-risk.html. Updated 2014.

5. Mt-Isa S, Wang N, Hallgreen CE, et al. Review of methodologies for benefit and risk assessment of medication. IMI-PROTECT Benefit-Risk Group. http://www.imi-protect.eu/benefit-risk.html. Updated 2013. Accessed November 25, 2014.

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