Bayesian Assessment of Safety Profiles in Clinical Trial Studies

• Activity Number: 15
• Type: Topic Contributed
• Date/Time: Sunday, August 9, 2015 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Judy Li* and Wei-Chen Chen and John Scott and Paul Mintz
• Companies: FDA and FDA and FDA and FDA
• Keywords: Bayesian ; Safety ; Clinical Trial Studies

Abstract

Safety assessment plays an important role in medical product development. Recently, Bayesian approaches have been increasingly used for assessing safety profiles in medical product development due to their natural ability to borrow strength across data. In this talk, we will discuss how to investigate the strength of borrowing in a Bayesian frame work by using different priors, such as mixture prior, commensurate prior, and etc. We will demonstrate our approach by applying it to both simulated data and the real data.