Bayesian Approaches for Benefit-Risk Assessment

• Activity Number: 16
• Type: Topic Contributed
• Date/Time: Sunday, August 9, 2015 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Ram Tiwari*
• Companies: FDA/CDER/OT/OB
• Keywords: Power prior, model selection, Dirichlet process

Abstract

An important aspect of the drug evaluation process is to have an integrated benefit-risk assessment to determine, using some quantitative measures, whether the benefit outweighs the risk for the target population. The subject-level benefit-risk response is a five-category random variable with their probabilities with respect to a reference category modeled, on the logarithmic scale, as a generalized linear model. Bayesian methods are proposed for the longitudinal assessment of benefit-risk using some global Benefit-risk measures. The model is applied to a clinical trial data.