Drug Evaluation Committee Considering the Disease Registry Ecosystem Toward the Promotion of Utilization of Disease Registries
Clinical Evaluation Subcommittee
June 2020
Disease registries exist in great numbers both in Japan and overseas, and their utilization for drug development is attracting attention.
In Task Force 1 of the Clinical Evaluation Subcommittee 2019, we considered that in order to promote the utilization of disease registries for drug development, it is desirable not only to achieve the initial purpose of establishing disease registries, but also to form a system of coexistence and co-prosperity through the continuous maintenance and utilization of disease registries by various stakeholders, in other words, the formation of a disease registry eco-system. In other words, it is desirable to form a disease registry eco-system.
In this task force, the disease registry ecosystem was conceived as "a system that returns to patients and their families the results generated by maximizing the use of the information and functions possessed by disease registries," and the elements for each stakeholder to form this ecosystem were examined.
We hope that this report will help facilitate discussions on the formation of a disease registry ecosystem for all stakeholders, including pharmaceutical companies considering the utilization of disease registries, as well as registry holders and governments.
2019TF-1 Subcommittee Document (1.5MB)
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