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Activity Number: 673 - Clinical Trial Design- 8
Type: Contributed
Date/Time: Thursday, August 2, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #327053
Title: Periodic Benefit-Risk Assessment Using Bayesian Stochastic Multi-Criteria Acceptability Analysis
Author(s): Sammy Yuan* and Kan Li and Bill Wang
Companies: Merck and University of Texas Health Science Center and Merck
Keywords: Structured denefit-risk assessment; periodic benefit-risk evaluation report; International Conference on Harmonization; Bayesian ; Meta-analysis; Stochastic multi-criteria acceptability analysis

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this talk, we propose a general statistical framework for PBRER, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose.

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

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