International harmonisation (clinical trial environment)

Committee:
Pharmaceuticals
status:
Some progress
Published:
Room for improvement on the efficiency of clinical trials in Japan.

Recommendations

  • 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.
  • Active discussions are being held among industry, government, and academia regarding improvements towards achieving efficient clinical trial operations. These improvements include the introduction of DCT (Decentralized Clinical Trial), promotion of RBA (Risk Based Approach) and cost rationalization, improvement of case accumulation capacity at individual sites, introduction of FMV (Fair Market Value) and consolidation of IRBs. Early realization of these improvements is anticipated.