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Multi-criteria decision analysis for benefit-risk analysis by national regulatory authorities

Chisholm, Orin, Sharry, Patrick and Phillips, Lawrence (2022) Multi-criteria decision analysis for benefit-risk analysis by national regulatory authorities. Frontiers in Medicine, 8. ISSN 2296-858X

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Identification Number: 10.3389/fmed.2021.820335


The approval process for pharmaceuticals has always included a consideration of the trade-offs between benefits and risks. Until recently, these trade-offs have been made in panel discussions without using a decision model to explicitly consider what these trade-offs might be. Recently, the EMA and the FDA have embraced Multi-Criteria Decision Analysis (MCDA) as a methodology for making approval decisions. MCDA offers an approach for improving the quality of these decisions and, in particular, by using quantitative and qualitative data in a structured decision model to make trade-offs in a logical, transparent and auditable way. This paper will review the recent use of MCDA by the FDA and EMA and recommend its wider adoption by other National Regulatory Authorities (NRAs) and the pharmaceutical industry.

Item Type: Article
Official URL:
Additional Information: © 2022 The Authors
Divisions: Management
Subjects: R Medicine > RM Therapeutics. Pharmacology
H Social Sciences > HD Industries. Land use. Labor
Date Deposited: 21 Mar 2022 09:36
Last Modified: 12 Jul 2024 20:24

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