2022 Fiscal Year Final Research Report
Study on drug utilization, research and development of intractable disease treatment using the database
Project/Area Number |
20K10388
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Research Category |
Grant-in-Aid for Scientific Research (C)
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Allocation Type | Multi-year Fund |
Section | 一般 |
Review Section |
Basic Section 58010:Medical management and medical sociology-related
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Research Institution | Tokai University |
Principal Investigator |
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Project Period (FY) |
2020-04-01 – 2023-03-31
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Keywords | 難病データベース / ランダム化介入試験 / リアルワールドデータ / エビデンス / 承認申請 |
Outline of Final Research Achievements |
Intractable diseases designated by the Ministry of Health, Labor and Welfare, which are serious and rare diseases, are stored in the registration database (intractable disease DB) for the purpose of subsidizing medical expenses. About 700,000 individual records, which hold valuable data, are accumulated every year. When the drug treatment information in the intractable disease DB was investigated, it was set medical products, which had already been approved as drug indications, as investigation items in the survey sheet, and information related to those medical products was collected. The data on off-label drug use were collected only for limited diseases survey sheets.
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Free Research Field |
規制科学
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Academic Significance and Societal Importance of the Research Achievements |
難病DBは研究活用も期待されているが、医療費補助申請を兼ねた症例登録として始まったDBであり、研究利用は限定的で、薬物治療を観点にした研究は未着手であった。今回、難病DBの薬物治療データの調査を行い、対象難病に対する効能効果を承認されている医薬品使用を中心としたデータ収集が行われており、適応外使用に関するデータ収集は限定的であった。今後、医薬品の使用成績調査との連携など、研究的な活用も期待できる。
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