Drug Evaluation Committee Examination of Study Design and Statistical Evaluation Methods in the Development of Regenerative Medicine Products
Data Science Subcommittee
May 2021
The peripheral industries of regenerative medicine in Japan and abroad are predicted to be a market that will develop dramatically in the future. In recent years, the establishment of regulations and systems based on the characteristics of regenerative medicine products and the promotion of their practical application in terms of finance have been carried out in Japan. In the FY2020 TF3, we will organize the regulations and guidance in Japan, the U.S., and Europe on the development of regenerative medical products, and after a close examination of application packages and review records of regenerative medical products approved in Japan and the U.S., we will propose study designs to be considered to improve the level of evidence and statistical evaluation methods to be considered to improve the efficiency of clinical trials. The report provides recommendations on study design to be considered to improve the level of evidence and on statistical evaluation methods to be considered to improve the efficiency of clinical trials. We hope that this report will trigger active discussions on the development of regenerative medicine products and Launch Excellence, and help to formulate scientific and efficient strategies.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee FY2020 Task Force 3
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