WITHDRAWN: Benefit-Risk Assessment Using Bayesian Joint Models of Safety and Efficacy

• Activity Number: 294
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Section on Bayesian Statistical Science
• Author(s): Jo A. Wick
• Companies: University of Kansas Medical Center
• Keywords: Benefit-risk ; Bayesian analysis

Abstract

Evaluating benefit-risk is critical to the evaluation of treatment options for patients, but the lack of a standard definition has resulted in a variety of methods. The Council for International Organizations of Medical Sciences (CIOMS) has stated that a major deficiency in the evaluation of a drug's benefit-risk is the lack of a "defined and tested algorithm or summary metric that combines benefit and risk data . . . that might permit straightforward quantitative comparisons of different treatment options" to aid in decision making. We introduce a Bayesian approach for assessing benefit-risk that jointly models data from primary safety and efficacy endpoints, including combinations of binary and continuous outcomes, and provides inferences for expected tradeoffs in benefit and risk that can enhance the patient-doctor conversation regarding competing treatment options.