SOME EXTENSIONS AND APPLICATIONS OF A BAYESIAN STRATEGY FOR MONITORING MULTIPLE OUTCOMES IN CLINICAL-TRIALS

We present some practical extensions and applications of a. strategy p roposed by Thall, Simon and Estey for designing and monitoring single- arm clinical trials with multiple outcomes. We show by application how the strategy may be applied to construct designs for phase IIA activi ty trials and phase II equivalence trials. We also show how it may be extended to incorporate the use of mixture priors in settings where a Dirichlet distribution does not adequately quantify prior experience, randomized phase II selection trials involving two or more experimenta l treatments, and trials with group-sequential monitoring for applicat ions involving multiple institutions. (C) 1998 John Wiley & Sons, Ltd.