4.1 Introduction

A typical drug development program may consist of multiple clinical studies with different study objectives, endpoints, and possibly different patient populations. There is rich literature for single trial Bayesian sample size determination [1-8]. Sutton et al. proposed a hybrid frequentist-Bayesian approach for sample size determination for a future randomized clinical trial (RCT) using the results of meta-analyses reported in the literature and suggested that the power can be highly dependent on the statistical model used for meta-analysis, and even very large studies may have little impact on a meta-analysis when there is considerable between study heterogeneity [9]. This raises a critical issue regarding how to appropriately ...

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