2019 Fiscal Year Final Research Report
A cost-evaluate enrichment design based on risk scores
| Project/Area Number |
17K15836
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Epidemiology and preventive medicine
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| Research Institution | Kurume University (2018-2019)
Aichi Medical University (2017) |
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Principal Investigator |
Murotani Kenta 久留米大学, 付置研究所, 准教授 (10626443)
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| Project Period (FY) |
2017-04-01 – 2020-03-31
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| Keywords | エンリッチメントデザイン / 感度・特異度 / 生物統計学 / リスクスコア |
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| Outline of Final Research Achievements |
Although conventional clinical trials conducted to date are uniformly assigned to all patients, following which the therapeutic efficacy is evaluated, investigators have recently been able to identify cases susceptible to events with comparatively high sensitivity and specificity following the advent of risk scores. By stratifying (enriching) certain patients to a high-risk group in advance using a risk score, investigators can expect to improve the overall efficiency and proficiency of conducting clinical trials; however, if the cost of score calculation increases, then following a conventional-style study protocol may result in lower total expenses in certain cases. Therefore, we developed an enrichment design based on the differences between groups and the sensitivity/specificity of the risk scores estimated with reference to test results evaluated by applying the conventional clinical trial results. We also developed a methodology for evaluating the costs of this design.
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| Free Research Field |
バイオ統計学
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| Academic Significance and Societal Importance of the Research Achievements |
昨今の臨床試験のトレンドはリスクスコア(バイオマーカーを含む)に基づいて患者集団を絞り込み効率化を図ることである。予後を正確に反映するリスクスコア開発が進む一方、真に臨床的意義のあるものから、そうでもないと考えられるものまで、様々なリスクスコアが乱立している。本研究は仮にあるリスクスコアを使って臨床試験を行った場合の総コスト評価を可能にするものである。より良い医療開発という目的の中には、コスト評価も重要な要素である。本研究は今後更に増えるであろうリスクスコアに基づく効率的な臨床試験のコスト評価の一助になることが期待できるものである。
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