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. 2022 Jan 12:8:820335.
doi: 10.3389/fmed.2021.820335. eCollection 2021.

Multi-Criteria Decision Analysis for Benefit-Risk Analysis by National Regulatory Authorities

Orin Chisholm  1   2   3 , Patrick Sharry  2   4 , Lawrence Phillips  5
Affiliations

Multi-Criteria Decision Analysis for Benefit-Risk Analysis by National Regulatory Authorities

Orin Chisholm et al. Front Med (Lausanne). .

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.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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