"To accelerate new drug development, clinical trial strategy has expanded to a global level with participation simultaneously from multiple geographical regions under the same study protocol. The possible benefits of this strategy are obvious but the challenges and issues with this strategy are many, including trial or data quality assurance, statistical methods for design and analysis ( to evaluate consistency of treatment effect across regions), difficulty in interpretation of regional differences, and the acceptability by the local regulatory authorities. In addition, an important challenge we are facing now is the lack of harmonization of regulatory guidance on MRCTs from ICH and EMA.

In this session, evaluation of statistical challenges and issues related to MRCT, statistical methods for design and analysis for evaluating consistency of treatment effect across regions, summary of current regulatory guidance on MRCT, and discussion on possible solutions and recommendation to deal with MRCT challenges and issues will be presented. In addition, practical consideration on agreement and harmonization for future MRCTs will be explored."