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

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  • Chisholm, Orin
  • Sharry, Patrick
  • Phillips, Lawrence

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.

Suggested Citation

  • Chisholm, Orin & Sharry, Patrick & Phillips, Lawrence, 2022. "Multi-criteria decision analysis for benefit-risk analysis by national regulatory authorities," LSE Research Online Documents on Economics 114407, London School of Economics and Political Science, LSE Library.
    • Handle: RePEc:ehl:lserod:114407
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    File URL: http://eprints.lse.ac.uk/114407/
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    References listed on IDEAS

    as
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    More about this item

    Keywords

    benefit-risk; decision analysis; drug approval process; regulatory affairs; regulatory science;
    All these keywords.

    JEL classification:

    • R14 - Urban, Rural, Regional, Real Estate, and Transportation Economics - - General Regional Economics - - - Land Use Patterns
    • J01 - Labor and Demographic Economics - - General - - - Labor Economics: General

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