Bayesian sequential meta‐analysis design in evaluating cardiovascular risk in a new antidiabetic drug development program

Recently, the Center for Drug Evaluation and Research at the Food and Drug Administration released a guidance that makes recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. One of the recommendations from the guidance is that phases II and III trials should be appropriately designed and conducted so that a meta‐analysis can be performed. In addition, the guidance implies that a sequential meta‐analysis strategy could be adopted. That is, the initial meta‐analysis could aim at demonstrating the upper bound of a 95% confidence interval (CI) for the estimated hazard ratio to be