Frontiers in Drug Safety and Regulation · Published 2026-06-10 · DOI 10.3389/fdsfr.2026.1792441
Jian-Yu E, Kexin Zhu, Stéphanie Tcherny-Lessenot, Juhaeri Juhaeri
BackgroundBenefit-risk assessment (BRA) can be challenging when integrating benefits, risks, and their relative importance as perceived by physicians or patients. This study aimed to compare eight BRA methodologies though the application and sights from a case study.MethodsEight BRA methodologies were evaluated using data from European Public Assessment Reports, randomized controlled trials, and published literature on rimonabant, including two descriptive frameworks, two quantitative frameworks, and four metrics and estimation techniques.ResultsDescriptive frameworks provided transparent, systematic approaches for structuring BRA and compared alternatives in a series of criteria assessment but lacked quantitative elements and stakeholder weighting. Quantitative frameworks extended these descriptive models by integrating objective data with subjective preferences, enabling the calculation of utility scores or acceptability indexes. Metrics enabled comparison of individual benefit and risk criteria, offering straightforward numerical evaluations.ConclusionA combination of descriptive and quantitative frameworks allows for a comprehensive BRA, accommodating multiple criteria, stakeholder’s preferences, and uncertainties.
Abstract from DOAJ. Public domain (CC0 1.0).
Read the article at the publisher →
E, J., Zhu, K., Tcherny-Lessenot, S., et al. (2026). Methodological comparisons for benefit-risk assessment in complex decision-making: applications and insights from a case study. Frontiers in Drug Safety and Regulation. https://doi.org/10.3389/fdsfr.2026.1792441