ABSTRACT
The landscape of drug development evolves with the globalization of the health industry as an integral part of the economy as well as public health worldwide. It is recognized that there are major advantages of being involved in conducting Multi-Regional Clinical Trials (MRCTs) as a part of it: Increasing drug development efficiency, promoting local or regional clinical research, providing local regulatory authorities a large body of data including their own patients studied under the same standard to evaluate the medical product, benefiting citizen patients to access new drugs around the same times as other nations. For these reasons, participating in various MRCTs globally is a rising trend for China as an emergent country in its biopharmaceutical industry and medical-health policy. China has joined the ICH as a member country in 2017. ICH E-17 contains general principles of MRCTs but lacks specifics. In this article, we highlight pertinent design and analysis issues with MRCTs and discuss current common approaches from the statistical aspects.
