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：
HIROTSU Chihiro
金额：
$ 2.3万
依托单位：
Meisei University
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：
https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-14580351/
关键词：
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 /

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.非劣层地毯的统一方法同时测试非劣质性假设性和超值假设具有兴趣。对于测试是STS的假设，已通过1999年提出的净元指南已达到0.025。它自然会对日本的临床试验实践产生很大的影响。为了证明仔细测试的测试药物的非外科性。测试药物对临床试验的态度，至少等效于4。响应分析在剂量反应分析中提出了一种估计剂量反应模式的新方法，该方法的经典估计剂量响应函数的目的是确定临床治疗的回收剂量。