| Project/Area Number |
16K00049
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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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| Research Field |
Statistical science
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| Research Institution | Osaka University (2017-2018)
Hiroshima University (2016) |
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Principal Investigator |
Hida Eisuke 大阪大学, 医学系研究科, 特任教授(常勤) (30469952)
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| Research Collaborator |
TANGO toshiro
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| Project Period (FY) |
2016-04-01 – 2019-03-31
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| Project Status |
Completed (Fiscal Year 2018)
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| Budget Amount *help |
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2018: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2017: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2016: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
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| Keywords | small clinical trial / 臨床試験デザイン / 分析感度 / 非劣性試験 / Network Meta-Analysis / 検証的試験 / Small Clinical Trials / 医学統計学 / 医薬品開発 / 希少疾病 |
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| Outline of Final Research Achievements |
As a result of this research, a new trial design and evaluation method for SCTs focusing on non-inferiority trials was proposed. In particular, assay sensitivity in non-inferiority trials must be evaluated from external information, because there is no internal control that can be evaluated directly. Therefore, we proposed two methods that can evaluate non-inferiority with the assay sensitivity. One is the proposal of the analysis method and the sample size calculation for the 3-arm non-inferiority trial including the placebo group. The results were published in Pharmaceutical Statistics. The other is the consideration of the method to evaluate the analysis sensitivity indirectly using Network Meta-Analysis, we reported the results at domestic and international conferences.
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| Academic Significance and Societal Importance of the Research Achievements |
本研究は，SCTsという適切な規模での臨床試験の実施が困難な場合における問題点を解決する新たな臨床試験デザインを提案することが目的である．非劣性試験はSCTsにおいても重要な比較デザインであり，非劣性試験が有する問題点である分析感度の保証に関しての新たなアプローチの提案は，SCTsに限定されることなく全ての疾患領域において，新治療薬に対する有効性を適切に評価することが可能なアプローチである．したがって，本研究により提案法を利用することで，画期的な治療の開発期間が短縮でき，有用な治療が早期承認されることに繋がることが予想される．
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