Pragmatic Multicriteria Decision Analysis (MCDA) Combined With Advanced Pharmacoepidemiology for Benefit-Risk Assessments of Medicines Adapted to the Real-Life Constraints of Regulators: Development and Case Study

Conclusions:
The approach allows quantification and visualization of benefit-risk over time and across comparators. Combination of pragmatic MCDA designed to integrate criteria beyond benefit-risk and advanced statistics supports application of MCDA to further accountable benefit-risk assessments for real-life decision making.

Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Goetghebeur, M. M., Wagner, M., Nikodem, M., Zyla, A., Micaleff, A., Amzal, B. Tags: Statistics Source Type: research