Examples from Medical Device Clinical Trials To Illustrate Advantages of the Bayesian Approach

• Activity Number: 373
• Type: Topic Contributed
• Date/Time: Wednesday, August 1, 2007 : 8:30 AM to 10:20 AM
• Sponsor: Section on Bayesian Statistical Science
• Author(s): Teresa Nelson*+
• Companies: Technomics Research, LLC
• Keywords: Bayesian ; Advantage ; Medical Device ; Clinical Trial ; Predictive Distribution ; Hierarchical Model

Abstract

The presentation will include examples illustrating advantages to Bayesian methods. The examples will include: 1) Utilization of prior data to reduce overall sample size by two methods (i.e., use of an informative prior and a hierarchical model). 2) Incorporation of multiple looks via a Bayesian design allows earlier trial stopping (i.e., less overall sample) than the typical frequentist group sequential design given the same assumptions about the underlying treatment effect and non-informative prior information. 3) Utilization of the predictive distribution to calculate probability of successful trial result based on the data collected to date in the trial and assumptions about the data yet to be observed/collected in the trial. 4) Ability to combine data from multiple sources via a Bayesian Meta-Analysis (Generalized Evidence Synthesis and a Random Effects Model).