Drug Evaluation Committee
Drug Development Utilizing Real World Data and Disease Registry
(1) Roadmap for the future of healthcare and drug development utilizing real-world data
2) Three requirements and seven proposals for utilizing real-world data in regulatory applications
3) Utilization of disease registries by pharmaceutical companies and trends in patient-participatory registries
Clinical Evaluation Subcommittee
May 2021
The Clinical Evaluation Subcommittee's FY2020 Task Force 1 discussed the requirements for utilizing real-world data (RWD) in regulatory applications and how to utilize the registry in order to disseminate concrete measures to relevant stakeholders, especially in the areas of rare diseases and intractable diseases, with the aim of quickly creating examples of utilization of RWD. In addition, the project has been working on the development of a registry for RWD. In addition, we drew a roadmap for a world in which utilization of RWD has advanced and a path (roadmap) for further discussion on the creation of real-world evidence in anticipation of further changes in the environment and GCP renovation in the future. We hope that the following three subcommittee documents will help you to realize a future where RWD is utilized in many aspects of drug development.
1) Roadmap for the future of healthcare and drug development utilizing real-world data (4.5MB)
We have drawn a vision of the future of healthcare in the year 2040, when further evolution is expected, and have indicated the position of RWD utilization in that vision. We also discussed measures and issues to realize this vision.
We summarized the requirements for the use of RWD in regulatory applications from the viewpoints of patients, regulatory authorities, and academia/medical institutions, which are the main stakeholders, as well as proposals from pharmaceutical companies.
Regarding the utilization of disease registries by pharmaceutical companies, we reviewed specific methods of utilization and summarized the usefulness, challenges, and expectations for the utilization of disease registries. In addition, overseas examples of patient-participatory disease registries were introduced and future prospects in Japan were discussed.
Deliverables of the Drug Evaluation Committee Return to list of all deliverables