A BAYESIAN GROUP SEQUENTIAL DESIGN FOR A MULTIPLE ARM RANDOMIZED CLINICAL-TRIAL

Group sequential designs for randomized clinical trials allow analyses of accruing data. Most group sequential designs in the literature concern the comparison of two treatments and maintain an overall prespecified type I error. As the number of treatments increases, however, so does the probability of falsely rejecting the null hypothesis. Bayesian statisticians concern themselves with the observed data and abide by the likelihood principle. As long as previous analyses do not change the likelihood, these analyses do not change Bayesian inference. In this paper, we discuss a group sequential design for a proposed randomized clinical trial comparing four treatment regimens. Bayesian ideas underlie the design and posterior probability calculations determine the criteria for stopping accrual to one or more of the treatments. We use computer simulation to estimate the frequentist properties of the design, information of interest to many of our collaborators. We show that relatively simple posterior probability calculations, along with simulations to calculate power under alternative hypotheses, can produce appealing designs for randomized clinical trials.