Various extensions of the isotonic regression problems and its applications
等渗回归问题的各种扩展及其应用
基本信息
- 批准号:14580351
- 负责人:
- 金额:$ 2.3万
- 依托单位:
- 依托单位国家:日本
- 项目类别:Grant-in-Aid for Scientific Research (C)
- 财政年份:2002
- 资助国家:日本
- 起止时间:2002 至 2005
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
1.A unifying approach to non-inferiority, equivalence and superiority tests via multiple decision processesIn 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 analysisIn 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.
1.在新药的比较临床研究中,通过多个决策过程进行了一种非差异,等效性和优越性检验的统一方法,反对对非效率假设的简单检验和优越性假设的简单测试的主动控制一直具有极大的兴趣。在日本,这两项测试的显着性水平通常设定为α= 0.05,但非劣效率假设的α已通过1999年引入的国际准则将其更改为0.025。它自然地对日本的临床试验产生了很大的影响,因为根据国际指南的规定,与旧级别相比,这是对旧级别的典范,这是在旧日本的典范中提供的,而不是提供1.3次的典范。 控制。这确实是一个非常严重的问题,需要仔细讨论,另请参见Hiratsu和Hothorn(2003)。在这项研究中,我们通过应用参数空间的分区原则成功地统一了日本旧准则和国际指南。这种方法特别有吸引力,改变了根据临床试验的实现,测试药物相对效率相对效率的证据的强度。它包括决策1。弱的非效率,2。强的非效率,3。至少等效,4。优越性。弱的不介绍性与日本实践相对应,对国际准则的强烈不介绍。还提出了另一种方法来利用日本和国际实践的优势。2。剂量反应分析在剂量反应分析中,提出了一种估计剂量响应模式的新方法,以取代剂量回应功能的经典估计。这个想法在第二阶段临床试验中非常有用,其目的是确定建议的临床治疗剂量。
项目成果
期刊论文数量(16)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Impact of the ICH E9 Guideline : Statistical principles for clinical trials on the conduct of clinical trials in Japan.
ICH E9 指南的影响:临床试验统计原则对在日本进行临床试验的影响。
- DOI:
- 发表时间:2003
- 期刊:
- 影响因子:0
- 作者:Hirotsu;C.;Hothorn;L.
- 通讯作者:L.
竹内 啓, 広津千尋, 公文雅之, 甘利俊一: "統計学の基礎II"岩波書店. 233 (2003)
Kei Takeuchi、Chihiro Hirotsu、Masayuki Kumon、Shunichi Amari:《统计学基础 II》岩波书店 233 (2003)。
- DOI:
- 发表时间:
- 期刊:
- 影响因子:0
- 作者:
- 通讯作者:
A unifing approach to non-inferiority, equivale and superiority tests via multiple decision processes.
通过多个决策过程进行非劣效性、等效性和优效性测试的统一方法。
- DOI:
- 发表时间:2006
- 期刊:
- 影响因子:0
- 作者:Hirotsu;C.
- 通讯作者:C.
Discussion oOn the roles of statistics in the life sciences
讨论统计学在生命科学中的作用
- DOI:
- 发表时间:2005
- 期刊:
- 影响因子:0
- 作者:Hirotsu;C.;M.Kuwada;守谷 智美;Chihiro Hirotsu
- 通讯作者:Chihiro Hirotsu
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HIROTSU Chihiro其他文献
HIROTSU Chihiro的其他文献
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{{ truncateString('HIROTSU Chihiro', 18)}}的其他基金
A unifying approach to the shape and change-point hypotheses based on doubly-accumulated statistics and its various applications
基于双累积统计的形状和变点假设的统一方法及其各种应用
- 批准号:
23500362 - 财政年份:2011
- 资助金额:
$ 2.3万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Efficient utilization of multiple decision processes in the research and development
在研发中有效利用多个决策流程
- 批准号:
18300096 - 财政年份:2006
- 资助金额:
$ 2.3万 - 项目类别:
Grant-in-Aid for Scientific Research (B)
Statistical Inference on Ordered Alternatives and Changepoint Hypotheses
有序替代方案和变点假设的统计推断
- 批准号:
11680321 - 财政年份:1999
- 资助金额:
$ 2.3万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Research on the mathematical structure of statistical inference and its application
统计推断的数学结构及其应用研究
- 批准号:
63302006 - 财政年份:1988
- 资助金额:
$ 2.3万 - 项目类别:
Grant-in-Aid for Co-operative Research (A)
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Integrated Interdisciplinary Training in Computational Neuroscience
计算神经科学综合跨学科培训
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