ABSTRACT
In recent decades, developing pharmaceutical products via multiregional clinical trials (MRCTs) has become a standard strategy. Traditionally, the treatment effect was assumed to have a fixed positive value over all regions in an MRCT. The literature is rich with proposals for the design and evaluation of MRCTs under the assumption of a common treatment effect
CONTENTS
19.1 Introduction .............................................................................................. 245 19.2 DREM for Heterogeneous Treatment Effect ......................................... 247 19.3 Hypothesis, Power for Benefit, and Sample Size Determination ...... 248 19.4 Power for Benefit and Consistency ........................................................ 249
19.4.1 Probability for Consistency (PC) under DREM .....................249 19.4.2 Optimal Allocation among Regions to Maximize PC ...........250 19.4.3 Probability for Benefit and Consistency (PBC) ......................251
