Outcome-adaptive allocation with natural lead-in for three-group trials with binary outcomes

ABSTRACT

Just as Bayes extensions of the frequentist optimal allocation design have been developed for the two-group case, we provide a Bayes extension of optimal allocation in the three-group case. We use the optimal allocations derived by Jeon and Hu Optimal adaptive designs for binary response trials with three treatments. Statist Biopharm Res. 2010;2(3):310–318] and estimate success probabilities for each treatment arm using a Bayes estimator. We also introduce a natural lead-in design that allows adaptation to begin as early in the trial as possible. Simulation studies show that the Bayesian adaptive designs simultaneously increase the power and expected number of successfully treated patients compared to the balanced design. And compared to the standard adaptive design, the natural lead-in design introduced in this study produces a higher expected number of successes whilst preserving power.