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

Research Project

Project/Area Number 09558024
Research Category

Grant-in-Aid for Scientific Research (B)

Allocation TypeSingle-year Grants
Section展開研究
Research Field Statistical science
Research InstitutionOsaka University

Principal Investigator

GOTO Masashi  Professor, Department/Division of Informatics and Mathematical Science, Graduate School of Engineering Sciences, Osaka University, 大学院・基礎工学研究科, 教授 (00273615)

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)
岩佐 学  大阪大学, 大学院・基礎工学研究科, 助手 (30232648)
Project Period (FY) 1997 – 1999
Project Status Completed (Fiscal Year 1999)
Budget Amount *help
¥12,100,000 (Direct Cost: ¥12,100,000)
Fiscal Year 1999: ¥3,500,000 (Direct Cost: ¥3,500,000)
Fiscal Year 1998: ¥3,400,000 (Direct Cost: ¥3,400,000)
Fiscal Year 1997: ¥5,200,000 (Direct Cost: ¥5,200,000)
Keywordsobservational 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 / データの省察 / 多変量小標体 / メタ・アナリシス / 交互作用 / CART / 偏り / 既存対照 / データ・マイニング
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.

Report

(4 results)
  • 1999 Annual Research Report   Final Research Report Summary
  • 1998 Annual Research Report
  • 1997 Annual Research Report
  • Research Products

    (37 results)

All Other

All Publications (37 results)

  • [Publications] Nakajima, T. Kitamura, M. & Goto, M. et al: "Adjuvant mitomycin and fluorouracil followed by oral uracil plus tegafur in serosa-negative gastric cancer : a randomized trial"The Lancet. 354. 273-277 (1999)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Goto, M. & Sugimmoto, T.: "Adjustment of the proportinal hazards model via characteristics of cases"Bulletin oh The International Statistical Institute, Book3, 52nd Session of ISI. 303-304 (1999)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Hamasaki, T. & Goto, M.: "Statistical inference based on grouped observations combined with ungrouped observations from power-normal distribution"Bulletin oh The International Statistical Institute, Book2, 52nd Session of ISI. 7-8 (1999)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Hamasaki, T., Isomura, T., Baba, M. & Goto, M.: "Statical approaches to finding the dose-response relationship"Drug Information Journal. 34(2). 125-136 (2000)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Kawai, N., Uwoi, T. & Goto, M.: "Statical approaches to accept foreign clinical data"Drug Information Journal. 34(3). 54-60 (2000)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] 武田 純・後藤昌司: "多変量小標本下での比較"応用統計学. 28(3). 21-29 (1999)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Goto, M. and Sugimoto, T.: "Adjustment of the proportional hazards model via characteristics of cases."Bulletin of The International Statistical Institute. Book3, 52nd Session of ISI. 303-304 (1999)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Nakajima, T., Kitamura, M. and Goto, M. et al.: "Adjuvant mitomycin and fluorouracil followed by oral uracil plus tegafur in serosa-negative gastric cancer : a randomized trial."The Lancet. 354. 273-277 (1999)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Hamasaki, T. and Goto, M.: "Statistical inference based on grouped observations combined with ungrouped observations from power-normal distribution."Bulletin of The International Statistical Institute. Book2, 52nd Session of ISI. 7-8 (1999)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Hamasaki, T., Isomura, T., Baba, M. and Goto, M.: "Statistical approaches to finding the dose-response relationship."Drug Information Journal. 34(2) (in press.). 125-136 (2000)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Kawai, N., Uwoi, T. and Goto, M. et al.: "Statistical approaches to accept foreign clinical data."Drug Information Journal.. 34(3) (in press.). 54-60 (2000)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Uesaka, H.: "Validity and applicability of tests for ordered alternatives with response for a clinical dose-response study."Journal of the Japanease Society of Computational Statistics. 11(1). 121-136 (1998)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Uesaka, H.: "Some considerations on handling rules for protocol deviations in clinical trials and related statistical analysis (in Japanease)."Japanease Journal of Applied Statistics. 26(2). 111-130 (1997)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Ochi, Y.: "Analysis of categorical data with extra-variation (in Japanease)."Proceedings of The Institute of Statistical Mathematics. 46(1). 205-225 (1998)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Hamasaki, T., Isomura, T., Ohtaki, M. and Goto, M: "Power transformation and its modifications (in Japanease)."Japanease Journal of Applied Statistics. 28(3) (in press.).

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Hamasaki, T., Isomura, T., Ohtaki, M. and Goto, M.: "Power transformation for observations with negative and positive values (in Japanease)."Bulletin of the Computational Statistics of Japan. 12(1) (in press.). (1999)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Takeda, J. and Goto, M.: "Comparison of highly small samples : Estimation of effective dimensionality in the Dempster's approximation test."Japanease Journal of Applied Statistics. 28(3) (in press.).

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Takeda, J. and Goto, M.: "Comparison of highly multivariate small samples : A test procedure with sample principal components (in Japanease)."The Japanease Journal of Behaviormetrics. 26(2) (in press.). (1999)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Sugimoto, T. and Goto, M.: "Adjustment of the proportional hazards model via characteristics of cases and its inference (in Japanease)."Bulletin of the Computational Statistics of Japan. 12(2) (in press.).

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Goto, M.: "Meanings and problems of meta-analysis (in Japanease)."Medical Treatment in Circular Disease Based on Mega-trials, ed. By Hori, S. and Kuwajima, I. Sentan Igaku Sha. 28-32

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1999 Final Research Report Summary
  • [Publications] Nakajima, T., Kitamura, M., & Goto, M. et al.: "Adjuvant mitomycin and fluorouracil followed by oral uracil plus tegafur in serosa-negative gastric cancer : a randomized trial"The Lancet. 354. 273-277 (1999)

    • Related Report
      1999 Annual Research Report
  • [Publications] Goto M & Sugunoto, T.: "Adjustment of the proportinal hazards model via characteristics of cases"Bulletin of The International Statistical Institute, Book3 ,52nd Session of ISI. 303-304 (1999)

    • Related Report
      1999 Annual Research Report
  • [Publications] Hamasaki, T. & Goto, M.: "Statistical inference based on grouped observations combined with ungrouped observations from power-normal distribution"Bulletin of The International Statistical Institute, Book3 ,52nd Session of ISI. 7-8 (1999)

    • Related Report
      1999 Annual Research Report
  • [Publications] Hamasaki. T.,Isomura, T. , Baba, M. & Goto, M.: "Statistical approaches to finding the dose-response relationship"Drug Information Journal. 34(2). 125-136 (2000)

    • Related Report
      1999 Annual Research Report
  • [Publications] Kawai. N., Uwoi. T. & Goto. M. et al.: "Statistical approaches to accept foreign clinical data"Drug Information Journal. 34(3). 54-60 (2000)

    • Related Report
      1999 Annual Research Report
  • [Publications] 武田純,後藤昌司: "多変量小標本下での比較"応用統計学. 28(3). 21-29 (1999)

    • Related Report
      1999 Annual Research Report
  • [Publications] Goto,M.& Sugimoto,T.: "Adjustment of the proportional hazard model via characterics of cases." The 52nd Session of the International Statistical Institute. 発表予定. (1999)

    • Related Report
      1998 Annual Research Report
  • [Publications] Hamasaki,T.& Goto,M.: "Some trasformation models for ordered categorical data and their applications." Statisitics in Medicine. 発表予定. (1999)

    • Related Report
      1998 Annual Research Report
  • [Publications] Kawai,N.& Goto,M.: "Relative performance of data-adaptive transformation for quantal response dara." Proceeding of Spring Conference of Korean Statistical Society. 1(2). 105-107 (1998)

    • Related Report
      1998 Annual Research Report
  • [Publications] Kuribayashi,K.& Goto,M.: "Gibbs sampling approach for exact conditional inference." Conference Papers of 3rd Conference on Statistical Computing of the Asian Regional Section.3(2). 289-298 (1998)

    • Related Report
      1998 Annual Research Report
  • [Publications] 馬場光正・後藤昌司: "用量・反応関係の推定" 日本計算機統計学会・第12回シンポジウム論文集. 12(1). 121-124 (1998)

    • Related Report
      1998 Annual Research Report
  • [Publications] 杉本知之・後藤昌司: "生存時間解析における退化調整モデル" 日本計算機統計学会・第12回シンポジウム論文集. 12(1). 137-140 (1998)

    • Related Report
      1998 Annual Research Report
  • [Publications] 後藤昌司・杉本知元: "メタ・アナリシスの意義・方法・問題点" 計量生物学. (発表予定). (1998)

    • Related Report
      1997 Annual Research Report
  • [Publications] Tsuji,M. & Goto,M.: "A clustering approach to regional structural analy as with its application." Proceedings of the 9th Korea and Japan Joint Conference of Statigtics. 218-222 (1997)

    • Related Report
      1997 Annual Research Report
  • [Publications] Imamura,K., Tamura,H., Goto,M. et al.: "Kansei structural modeling for virtual Ritchen design system." Proceedings of the 1st Japan-Korea Symposium on Kansei Engineering-Consumer-Oriented Product D & T.63-68 (1997)

    • Related Report
      1997 Annual Research Report
  • [Publications] Imamura,K., Tamura,H. Goto,M. et al.: "Hierarchical structure of customer's image based on sensory measurements." Behaviormetrika. (発表予定). (1998)

    • Related Report
      1997 Annual Research Report
  • [Publications] 後藤昌司: "メガトライアルから学ぶ循環器疾患の治療 (編者:堀正二・桑島厳" メタ・アナリシスの意義と問題点 先端医学社, (1998)

    • Related Report
      1997 Annual Research Report

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Published: 1997-04-01   Modified: 2016-04-21  

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