Drug Evaluation Committee Expectations for Policies to Promote Secondary Use of Real World Data in Drug Development
Clinical Evaluation Subcommittee
May 2024
In recent years, policy policies have been presented and specific discussions and examinations have been conducted to promote the secondary use of real world data (RWD) as a data source for clinical research, etc., in addition to the primary use of RWD for diagnosis and treatment of individual patients, etc. As a result of these discussions and examinations, the RWD utilization policy has been established.
As a result, although the environment for the utilization of RWD has been steadily improving, challenges still remain for pharmaceutical companies to fully utilize RWD for secondary use in drug development. Therefore, in FY2022/2023, the Clinical Evaluation Subcommittee and the Team for Addressing Ongoing Issues10 summarized expectations for solving the remaining issues from the standpoint of secondary use of RWD for drug development by surveying and organizing various policies and projects related to the secondary use of RWD.
We hope that this report will help stakeholders promoting RWD policies and projects and pharmaceutical companies utilizing RWD in drug development to deepen their understanding of issues related to the secondary use of RWD in drug development and to work together to build a better environment.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Clinical Evaluation Subcommittee, Continuing Issues Response Team 10
Expectations for Policies to Promote Secondary Use of Real World Data in Drug Development
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