Research of Statistical Data Analysis Process Based on Harmonaization of Experimental and Olservational Studies

基于实验与观察研究协调的统计数据分析过程研究

基本信息

批准号：
09558024
负责人：
GOTO Masashi
金额：
$ 7.74万
依托单位：
Osaka University
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (B)
财政年份：
1997
资助国家：
日本
起止时间：
1997 至 1999
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-09558024/
关键词：
observational studies survival CART recursive partitioning dose-response relationships equivalence assessment bridging study data investigations saddle point approximation highly multivariate small sample power-transformation 同位性の評価

项目摘要

The purposes of the project are to research and develop some methodologies which can be used in both experimental and observational studies. Particularly, in experimental studies we have focused on a posteriori analysis of data in each experiment from the view of observational studies. Further, in observational studies, we provided some methods and approaches of cause-effect inference, which include tree structured methods, i.e., CART, Survival CART and MARS. In the project research, we could obtain the following results and some productive findings :We have provided the process of evaluating quality of experimental studies and re-investigated cycle of experiments, especially diagnosis of experimental studies.As a posteriori analysis of the experimental data, we have provided inference methods from "samples to individuals", for instance, from "medical treatments (drugs) to disease" to "cure (drugs) to patient" based by constructing individual profiles based on tree structured methods.In survival analysis, we have developed adjusted proportional hazard model which took account of long survivors for ordinary model, and applied the model to cancer data. Consequently, the model had exhaustive and data-adaptive properties, so it was shown to have useful applications in medical and/or clinical studies.For recent issues of ICH in clinical trials, we have proposed some models and approaches to bridging between concurrent trial and foreign clinical trials, and shown the usefulness of usefulness of the approaches by applying to some practical data.Particularly, inference of dose-response relationships have been widely and systematically investigated, some models and/or approaches have been proposed from the view of estimation of cumulative distribution function, and the utility of the models and/or approaches have been shown by conducting many simulations and trials to literature data.

该项目的目的是研究和开发一些可以在实验和观察性研究中使用的方法。特别是在实验研究中，我们从观察性研究的角度将每个实验的数据后验分析集中在数据分析上。此外，在观察性研究中，我们提供了一些因果推理的方法和方法，其中包括树结构化方法，即购物车，生存购物车和火星。在项目研究中，我们可以获得以下结果和一些富有成效的发现：我们提供了评估实验研究质量和重新研究实验周期的质量的过程，尤其是对实验研究的诊断。作为实验数据的后验分析，我们根据“基于“药物”（药物）的corsection（药物），我们提供了从“样本到个体”的推理方法。在生存分析中，我们开发了调整后的比例危害模型，该模型考虑了长期存活者的普通模型，并将该模型应用于癌症数据。因此，该模型具有详尽和数据自适应的特性，因此被证明在医学和/或临床研究中具有有用的应用。对于ICH的最新问题，在临床试验中，我们提出了一些模型和方法，并在并行试验和外国临床试验之间进行桥接，并显示出某些实用性的数据的有用性，并证明了这些方法的实用性。研究了一些模型和/或方法，从估计累积分布函数的观点中提出了一些模型和/或方法，并且通过对文献数据进行许多仿真和试验来显示模型和/或方法的效用。