| Project/Area Number |
18K09939
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Review Section |
Basic Section 58010:Medical management and medical sociology-related
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| Research Institution | The University of Tokyo |
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Principal Investigator |
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| Project Period (FY) |
2018-04-01 – 2021-03-31
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| Project Status |
Completed (Fiscal Year 2020)
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| Budget Amount *help |
¥3,510,000 (Direct Cost: ¥2,700,000、Indirect Cost: ¥810,000)
Fiscal Year 2020: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2019: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2018: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
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| Keywords | 新薬開発 / 臨床試験 / 臨床試験デザイン / 新規医薬品開発 / 新薬申請 / ベイズ / ベイジアン / FDA / PMDA / 治験 / 早期臨床試験 / 承認確率 / 第I相試験 |
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| Outline of Final Research Achievements |
The cost of developing a new drug is enormous, but the probability of approval after the first phase I trial estimated to be just over 10%, and is even more severe in oncology. In this study, we explored the risk factors associated with discontinuation of new drug development and modeled the probability of drug approval by using publicly available information from clinicaltrials.gov and the U.S. Food and Drug Administration (FDA). The database covers development period, whether phase II and phase III trials were conducted, and other information. We found that new drugs in oncology have been in development for more than 10 years and more than half of drugs have not yet been approved even after reaching Phase III trials. We will explore the factors associated with the risk of discontinuation in such late phases.
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| Academic Significance and Societal Importance of the Research Achievements |
現在本邦においても研究者主導治験・臨床試験が盛んに行われるようになり、新薬開発の機運は高まっているが、開発失敗のリスクというのは研究者にとっても、パートナーとなる製薬企業にとっても重大な問題である。特に、膨大な投資を行った上での後期相での開発中止はより大きな問題と考えられ、その頻度を明らかにし関連する因子を探っていくというのが本研究の目的である。現在、研究用のデータベースが完成間近であり、記述統計的な結果の提示にとどまってはいるが、開発が長期化している実態や第III相での開発中止例が想定以上に多いことが明らかとなるなどの成果が得られている。
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