ArticleFrontiers in drug safety and regulation2026
Methodological comparisons for benefit-risk assessment in complex decision-making: applications and insights from a case study.
Article in Frontiers in drug safety and regulation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Benefit-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. Methods: Eight 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. Results: Descriptive 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. Conclusion: A combination of descriptive and quantitative frameworks allows for a comprehensive BRA, accommodating multiple criteria, stakeholder's preferences, and uncertainties.
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