Using the Incremental Net Benefit Framework for Quantitative Benefit–Risk Analysis in Regulatory Decision-Making—A Case Study of Alosetron in Irritable Bowel Syndrome

OBJECTIVE: There is consensus that a more transparent, explicit, and rigorous approach to benefit-risk evaluation is required. The objective of this study is to evaluate the incremental net benefit (INB) framework for undertaking quantitative benefit-risk assessment by performing a quantitative benefit-risk analysis of alosetron for the treatment of irritable bowel syndrome from the patients' perspective. METHODS: A discrete event simulation …