International harmonisation (clinical trial environment)

Room for improvement on the efficiency of clinical trials in Japan.


  • Although various efforts to date to improve clinical trial efficiency have improved the environment for conducting clinical trials in Japan, it is essential to make improvements to achieve more efficient clinical trial operations compared to international standards in order to continue to develop innovative drugs. For example, we propose to discuss the introduction of DCT (Decentralized Clinical Trial), improvement of case accumulation capacity at individual sites, and consolidation of IRBs in order to realize efficient clinical trial operations.
  • Japan should further enhance the efficiency of drug development by taking advantage of the new guidelines on multi-regional clinical trials (ICH E17, GENERAL PRINCIPLES FOR PLANNING AND DESIGN OFMULTI-REGIONAL CLINICAL TRIALS) that was published in June 2018.