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

Orin Chisholm, Patrick Sharry and Lawrence Phillips

LSE Research Online Documents on Economics from London School of Economics and Political Science, LSE Library

Abstract: 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.

Keywords: benefit-risk; decision analysis; drug approval process; regulatory affairs; regulatory science (search for similar items in EconPapers)
JEL-codes: J01 R14 (search for similar items in EconPapers)
Pages: 7 pages
Date: 2022-01-12
New Economics Papers: this item is included in nep-ban and nep-reg
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Published in Frontiers in Medicine, 12, January, 2022, 8. ISSN: 2296-858X

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