Drug Evaluation Committee How Much of the Existing Domestic Real World Data Can Be Used for Drug Development?

Clinical Evaluation Subcommittee

May 2019

With the aim of promoting the use of RWD in domestic drug development, the committee examined the extent to which existing databases (DBs) of domestic real-world data (RWD) 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, it will be useful in selecting a DB 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.

Pharmaceutical Cooperative Clinical Evaluation Subcommittee TF2_SG3_Subcommittee Document (1.5MB)

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