Drug Evaluation Committee Disease Registries in Drug Development: Analysis of Current Status and Prospects
Clinical Evaluation Subcommittee
June 2019
There are many disease registries in Japan and abroad, but few of them have been surveyed and reported on their actual utilization in drug development.
In TF-1 of the Clinical Evaluation Committee in 2018, we will summarize the general situation of disease registries in Japan and abroad, and analyze the utilization of disease registries in drug development in the fields of neurological and psychiatric diseases, rare diseases, and other diseases. The status of disease registries in nine disease areas (neurological and psychiatric diseases, rare and intractable diseases, pediatric diseases, oncology, lifestyle-related diseases, urological and visceral diseases, infectious diseases, immunological and allergic diseases, and regenerative medicine) was surveyed and summarized by case of utilization.
We hope that this report will help the development of disease registries in Japan and promote the use of disease registries not only in medical research in the medical field and academia, but also in drug development by pharmaceutical companies.
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