Global Landscape of Benefit-Risk Considerations for Medicinal Products: Current State and Future Directions

Pharmaceut Med. 2022 Aug;36(4):201-213. doi: 10.1007/s40290-022-00435-x. Epub 2022 Jul 3.


In the last decade there has been a significant increase in the literature discussing the use of benefit-risk methods in medical product (including devices) development. Government agencies, medical product industry groups, academia, and collaborative consortia have extensively discussed the advantages of structured benefit-risk assessments. However, the abundance of information has not resulted in a consistent way to utilize these findings in medical product development. Guidelines and papers on methods, even though well structured, have not led to a firm consensus on a clear and consistent approach. This paper summarizes the global landscape of benefit-risk considerations for product- or program-level decisions from available literature and regulatory guidance, providing the perspectives of three stakeholder groups-regulators, collaborative groups and consortia, and patients. The paper identifies key themes, potential impact on benefit-risk assessments, and significant future trends.

MeSH terms

  • Forecasting
  • Government Agencies*
  • Humans
  • Industry*
  • Risk Assessment