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

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.