Practice and Guidance for Conducting Bayesian Interim Analyses in Clinical Trials

The theory and methods for the Bayesian Interim Analysis for Clinical Trials are motivators for this presentation. Introductions to the Bayesian statistics, Bayesian Inference, and interim analysis for clinical trials are provided, along with detailed discussion of the theory. Practical examples of the Bayesian interim analysis for clinical trials are provided to illustrate the methods. The Bayesian predictive probability approach, Interval estimation approach and posterior distribution summary approach on the Normal and Binomial distributed data are also discussed. Bayesian inference simulations were performed. Discussions are provided to the FDA's guidance and opinion on Bayesian analysis, as well as FDA's approval history on Bayesian analyzed clinical trials.