Drug Evaluation Committee How far existing domestic real-world data can be utilized for drug development
Clinical Evaluation Subcommittee
May 2019
With the aim of promoting the use of RWD in domestic drug development, we examined the extent to which existing domestic real-world data (RWD) databases (DBs) can be used in typical drug development situations.
- The report is intended to help non-pharmaceutical companies learn about the specifics of the use of RWD in drug development.
- RWDs reviewed】 JMDC, MDV, HCEI/RWD, Chloe (changed its name to 3H Medisolutions Inc. in April 2019), SCRUM-Japan
For pharmaceutical companies that have not yet utilized RWD, we believe this will serve as an opportunity to introduce RWD, and for companies that have already introduced RWD, this will be useful in selecting DBs and further utilizing RWD in drug development. We hope that this report will provide non-pharmaceutical companies with concrete information on the use of RWD in drug development.
JPMA Clinical Evaluation Subcommittee TF2_SG3_Subcommittee Document (1.5MB)