| Co-Investigator(Kenkyū-buntansha) |
TAGO Yoshio Professor, Department of Computational Science, Faculty of Science, Kanazawa University, 理学部・計算科学科, 教授 (80303254)
OCHI Yoshimichi Associate Professor, Department of Computer Science and Intelligent Systems, Oita University, 工学部・知能情報システム工学科, 助教授 (60185618)
SHIRAHATA Shingo Professor, Department/Division of Informatics and Mathematical Sciences, Graduate School of Engineering Sciences, Osaka University, 基礎工学研究科, 教授 (10037294)
SAKAMOTO Wataru Assistant, Department/Division of Informatics and Mathematical Sciences, Graduate School of Engineering Sciences, Osaka University, 基礎工学研究科, 助手 (70304029)
上坂 浩之 日本イーライ・リリー株式会社, 医学・科学部門・臨床開発部・臨床統計室, 室長
INAGAKI Nobuo Professor, Department/Division of Informatics and Mathematical Sciences, Graduate School of Engineering Sciences, Osaka University (10000184)
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| Research Abstract |
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.
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