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Activity Number: 338 - BIOP Student Paper Awards
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #328429
Title: Bayesian Personalized Multi-Criteria Benefit-Risk Assessment of Medical Products
Author(s): Kan Li* and Sammy Yuan and Sheng Luo
Companies: University of Texas Health Science Center and Merck and Duke University Medical Center
Keywords: patient centered approach; benefit-risk assessment; SMAA; MCMC

In response to the Patient-Centered Benefit-Risk (PCBR) project commissioned by the FDA, we propose a Bayesian personalized multi-criteria decision-making method for benefit-risk (BR) assessment of medical products. This method is based on a novel multidimensional latent trait model and a stochastic multi-criteria acceptability analysis approach. It effectively accounts for the subject-level differences in treatment effects, dependencies among BR criteria, and incorporates imprecise and heterogeneous patient preference information. One important feature of the proposed method is that it focuses on the perspective of patients who live with a disease and are directly impacted by the regulatory decision and treatment selection. We apply our method to a case study in a post hoc way to illustrate how it may improve the transparency and consistency of the treatment decision-making process. The proposed method facilitates the communication of treatment decisions between healthcare providers and individual patients based on a personalized BR profile. It could also be an important complement to the PCBR and help to move a step closer towards a patient-centric regulatory approval process.

Authors who are presenting talks have a * after their name.

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