A dynamic power prior for borrowing historical data in noninferiority trials with binary endpoint.

Traditionally, noninferiority hypotheses have been tested using a frequentist method with a fixed margin. Given that information for the control group is often available from previous studies, it is interesting to consider a Bayesian approach in which information is "borrowed" for the control group to improve efficiency. However, construction of an appropriate informative prior can be challenging. In this paper, we consider a hybrid Bayesian approach for testing noninferiority hypotheses in studies with a binary endpoint. To account for heterogeneity between the historical information and the current trial for the control group, a dynamic P value-based power prior parameter is proposed to adjust the amount of information borrowed from the historical data. This approach extends the simple test-then-pool method to allow a continuous discounting power parameter. An adjusted α level is also proposed to better control the type I error. Simulations are conducted to investigate the performance of the proposed method and to make comparisons with other methods including test-then-pool and hierarchical modeling. The methods are illustrated with data from vaccine clinical trials.