Design and Data Analysis of Multiregional Clinical Trials (MRCTs)—Theory and Practice

In recent years, multiregional clinical trial (MRCT)Multiregional clinical trial (MRCT) has become a preferredPreferred terms strategy to develop new medicines. Implementing the same protocol to include subjects from many geographical regions around the world, MRCTs could speed up the patient enrollment, thus resulted in a quicker drug development and obtain faster approval of the drug globally. At the same time, the MRCT strategy is expected to maintain the sample sizeSample size at the similar level, i.e., without significantly driving up the cost and slowing down the speed of the development.