Impact of Different Regulatory Requirements for Trial Endpoints in Multiregional Clinical Trials

摘要

Generation of evidence to meet regulatory standards for product registration requires increasingly large product development programs and data packages (1). Expanding clinical trial sites globally may enable more efficient product development (2,3), enhancing product afford-ability and fostering further investment in R&D. Different requirements by regulatory agencies in different parts of the world create significant challenges in the study design and conduct of multiregional clinical trials (MRCTs).