| Project/Area Number |
14580351
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Statistical science
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| Research Institution | Meisei University |
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Principal Investigator |
HIROTSU Chihiro Meisei University, Science and Technology, Professor, 理工学部, 教授 (60016730)
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| Project Period (FY) |
2002 – 2005
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| Project Status |
Completed (Fiscal Year 2005)
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| Budget Amount *help |
¥3,600,000 (Direct Cost: ¥3,600,000)
Fiscal Year 2005: ¥800,000 (Direct Cost: ¥800,000)
Fiscal Year 2004: ¥900,000 (Direct Cost: ¥900,000)
Fiscal Year 2003: ¥900,000 (Direct Cost: ¥900,000)
Fiscal Year 2002: ¥1,000,000 (Direct Cost: ¥1,000,000)
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| Keywords | Comparative clinical study / Dose - response analysis / Life science and statistical science / Non-inferiority test / Multiple decision processes / Superiority test / 凹凸パターン / 拡張max t検定 / 血圧24時間値 / 最適実験計画 / max min検定 / プロファイル解析 / クラスタリングアルゴリズム / 血圧日内リズム / 交互作用多重比較 / 凸性仮説 / 単調仮説 / 変化点問題 / 用量・反応解析 |
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| Research Abstract |
1.A unifying approach to non-inferiority, equivalence and superiority tests via multiple decision processes
In the comparative clinical study of a new drug against an active control the simultaneous testing of the non-inferiority hypothesis and the superiority hypothesis has been of great interest. In Japan the significance level of these two tests was set commonly at α=0.05 but the α for the non-inferiority hypothesis has been altered to 0.025 by the International Guideline introduced in 1999. It naturally gives a very big impact on the Japanese practice of clinical trial since according to the International Guideline approximately 1.3 times the sample size is required as compared with the old Japanese practice for proving the non-inferiority of a test drug which is truly equivalent to the control. This is indeed a very serious problem to be discussed carefully, see also Hirotsu and Hothorn (2003). In this research we succeeded in unifying the old Japanese Guideline and the International Guideline by applying the partitioning principle of the parameter space. This method is particularly attractive changing the strength of the evidence of relative efficacy of the test drug against a control according to the achievement of the clinical trial. It includes the decisions 1. weak non-inferiority, 2. strong non-inferiority, 3. at least equivalence, and 4. superiority. The weak non-inferiority corresponds to the Japanese practice and the strong non-inferiority to the International Guideline. Yet another approach has also been proposed taking the advantages of both of the Japanese and International practices.
2.Dose - response analysis
In the dose-response analysis a new approach of estimating the dose - response patterns is proposed replacing the classical estimation of dose-response function. This idea is very useful in the phase 2 clinical trial whose purpose is to decide the recommended dose for the clinical treatment.
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