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Statistical Methodologies for Improving Predictability in Clinical Research and Development of Drugs

Research Project

Project/Area Number 20500255
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field Statistical science
Research InstitutionOsaka University

Principal Investigator

HAMASAKI Toshimitsu  Osaka University, 医学系研究科, 准教授 (40379243)

Co-Investigator(Kenkyū-buntansha) SUGIMOTO Tomoyuki  大阪大学, 医学系研究科, 助教 (70324829)
SOZU Takashi  京都大学, 医学研究科, 准教授 (80408723)
UESAKA Hiroyuki  大阪大学, 臨床医工学融合研究教育センター, 特任教授 (60446250)
Project Period (FY) 2008 – 2010
Project Status Completed (Fiscal Year 2010)
Budget Amount *help
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2010: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2009: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2008: ¥2,470,000 (Direct Cost: ¥1,900,000、Indirect Cost: ¥570,000)
Keywords医薬品開発 / 生物統計学 / 標本サイズ / 臨床試験 / 多重評価項目 / 統計的シミュレーション / 多重評価指標 / 適応的デザイン / 標本サイズの設定 / 確率化操作
Research Abstract

Statistical methodologies for Improving predictability in clinical research and development of drugs with shorten the time, saving the cost, and improving productivity were considered. (1) the exponential cure classification and regression tree (CART) was newly developed to indentify the patients group with higher risks of remissions and recurrence of diseases, especially with application of major depressive disorder and the statistical simulation for assessment of clinical trial designs were performed with the models suggested model. (2) Performances of randomization methods frequently used in clinical trials were theoretically and numerically assessed. In addition, issues in groups sequential design with sample size modification based on multiple co-primary endpoints were discussed. (3) Power and sample size determinations in clinical trials with multiple correlated continuous, binary and time to events endpoints were discussed and some guidance was provided to how to consider the correlation between the endpoints in power and sample size determinations.

Report

(4 results)
  • 2010 Annual Research Report   Final Research Report ( PDF )
  • 2009 Annual Research Report
  • 2008 Annual Research Report
  • Research Products

    (57 results)

All 2011 2010 2009 2008 Other

All Journal Article (28 results) (of which Peer Reviewed: 28 results) Presentation (23 results) Book (5 results) Remarks (1 results)

  • [Journal Article] Sample size determination in superiority clinical trials with multiple co-primary correlated end-points.2011

    • Author(s)
      Sozu T, Sugimoto T, Hamasaki T
    • Journal Title

      Journal of Biopharmaceutical Statistics in press

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] A simple modification of the Box and Cox trans-formation to scale stability and invariance.2011

    • Author(s)
      Hamasaki T, Sugimoto T, Kim SY
    • Journal Title

      Jour-nal of the Japanese Society of Computational Statistics in press

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] 相関をもつ二つの変数の比に対する解析2011

    • Author(s)
      朝倉こう子, 上坂浩之, 杉本知之, 濱崎俊光
    • Journal Title

      応用統計学 印刷中

    • NAID

      10028209457

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Sample size determination in superiority clinical trials with multiple co-primary correlated endpoints2011

    • Author(s)
      Sozu T, Sugimoto T, Hamasaki T
    • Journal Title

      Journal of Biopharmaceutical Statistics

      Volume: (印刷中)

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] A simple modification of the Box and Cox transformation to scale stability and invariance2011

    • Author(s)
      Hamasaki T, Sugimoto T, Kim SY
    • Journal Title

      Journal of the Japanese Society of Computational Statistics

      Volume: (印刷中)

    • NAID

      10030497138

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] 相関をもつ二つの変数の比に対する解析2011

    • Author(s)
      朝倉こう子, 上坂浩之, 杉本知之, 濱崎俊光
    • Journal Title

      応用統計学

      Volume: (印刷中)

    • NAID

      10028209457

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Practical issues and lessons learned from multi-regional clinical trials via case examples : A Japanese perspective.2010

    • Author(s)
      Ando Y, Hamasaki T
    • Journal Title

      Pharmaceutical Statistics 9

      Pages: 190-200

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Sample size determination in clinical trials with multiple co-primary binary endpoints.2010

    • Author(s)
      Sozu T, Sugimoto T, Hamasaki T
    • Journal Title

      Statistics in Medicine 29

      Pages: 2169-2179

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Practical application of cure mixture model to long-term censored survivor data from a withdrawal clinical trial of patients with major depressive disorder.2010

    • Author(s)
      Arano I, Sugimoto T, Hamasaki T, Ohno Y
    • Journal Title

      BMC Medical Research Me-thodology 10(33)

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Box and Cox power-transformation to additivity and homoscedasticity in regression2010

    • Author(s)
      Hamasaki T, Sugimoto T, Goto, M
    • Journal Title

      Journal of the Japanese Society of Computational Statistics

      Volume: 23(1) Pages: 13-26

    • NAID

      10027129411

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Practical issues and lessons learned from multi-regional clinical trials via case examples : A Japanese perspective2010

    • Author(s)
      Ando Y, Hamasaki T
    • Journal Title

      Pharmaceutical Statistics

      Volume: 9 Pages: 190-200

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Sample size determination in clinical trials with multiple co-primary binary endpoints2010

    • Author(s)
      Sozu T, Sugimoto T, Hamasaki T
    • Journal Title

      Statistics in Medicine

      Volume: 29 Pages: 2169-2179

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Practical application of cure mixture model to long-term censored survivor data from a withdrawal clinical trial of patients with major depressive disorder2010

    • Author(s)
      Arano I, Sugimoto T, Hamasaki T, Ohno Y
    • Journal Title

      BMC Medical Research Methodology

      Volume: 10(33) Pages: 33-33

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Influence of voluntary control of masticatory side 5 and rhythm on cerebral hemodynamics2010

    • Author(s)
      Hasegawa Y., at al.
    • Journal Title

      Clinical Oral Investigations (in press)

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Ocular risk factors for choroidal neovascularization in pathological myopia2010

    • Author(s)
      Ikuno Y., at al.
    • Journal Title

      Investigative Ophthalmology & Visual Science (in press)

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Opening velocity, a novel parameter, for finger tapping test in pa-tients with Parkinson's disease.2009

    • Author(s)
      Yokoe M, Okuno R, Hamasaki T, Kurachi Y, Akasawa K, Sakoda S
    • Journal Title

      Parkinsonism & Related Disorders 15

      Pages: 440-444

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Quantitative cha-racterizations of postural sway during human quiet standing using a thin pressure distribution measurement system.2009

    • Author(s)
      Nomura K, Fukada K, Azuma T, Hamasaki T, Sakoda S, Nomura T
    • Journal Title

      Gait & Posture 29

      Pages: 654-657

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Sample size allocation to regions in a multiregional trial.2009

    • Author(s)
      Uesaka H.
    • Journal Title

      Journal of Bio-pharmaceutical Statistics 19

      Pages: 580-594

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Practical Considerations in Sample Size Deter-mination of Japanese Subgroup for a Mul-ti-Regional Oncology Clinical Trial.2009

    • Author(s)
      Ogawa S, Sekiguchi R, Uesaka H.
    • Journal Title

      Japanese Journal of Biometrics 30

      Pages: 81-107

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Immunotherapy of ovarian cancer with cell wall skeleton of Mycopbacterium bovis Bacillus Calmette-Guerin : Effect of lymphadenectomy2009

    • Author(s)
      Hayashi A., et al.
    • Journal Title

      Cancer Science 100

      Pages: 1991-1995

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Intravitreal bevacizumab vs sub-tenon triamcinolone acetonide for choroidal neovascularization attributable to pathologic myopia2009

    • Author(s)
      Wakabayashi T., et al.
    • Journal Title

      American Journal of Ophthalmology 148

      Pages: 591-596

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Sample size allocation to regions in a multiregional trial2009

    • Author(s)
      Uesaka
    • Journal Title

      Journal of Biopharmaceutical Statistics 19

      Pages: 580-594

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Practical Considerations in Sample Size Determination of Japanese Subgroup for a Multi-Regional Oncology Clinical Trial2009

    • Author(s)
      Ogawa, S., et al
    • Journal Title

      Japanese Journal of Biometrics 30

      Pages: 81-107

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Prognostic factors and outcome prediction model of severe traumatic brain injury2009

    • Author(s)
      Tasaki, 0., et al.
    • Journal Title

      The Journal of Trauma, Injury, Infection, and Critical Care 66

      Pages: 304-308

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Opening velocity, a novel parameter, for finger tapping test in patients with Parkinson' s disease2009

    • Author(s)
      Yokoe, M., et al.
    • Journal Title

      Parkinsonism & Related Disorders (in press)

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Quantitative characterizations of postural sway during human quiet standing using a thin pressure distribution measurement system2009

    • Author(s)
      Nomura, K., et al.
    • Journal Title

      Gait & Posture (in press)

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Evaluation of clustering base on preprocessing in gene expres-sion data.2008

    • Author(s)
      Kim SY, Hamasaki T
    • Journal Title

      International Journal of Biological & Life Sciences 3

      Pages: 48-53

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Evaluation of clustering base on preprocessing in gene expression data2008

    • Author(s)
      Kim, S. Y., et al.
    • Journal Title

      International Journal of Biological, Biomedical and Medical Sciences 3

      Pages: 48-53

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Presentation] Statistical considerations for a multiregional bridging trial2011

    • Author(s)
      Uesaka H
    • Organizer
      The Second International Symposium on Biopharmace utical Statistics
    • Place of Presentation
      Berlin, Germany(招待講演)
    • Year and Date
      2011-03-01
    • Related Report
      2010 Annual Research Report
  • [Presentation] Statistical considerations for a multiregional bridging trial.2011

    • Author(s)
      上坂浩之
    • Organizer
      The Second International Symposium on Biopharmaceutical Statistics
    • Place of Presentation
      Berlin, Germany
    • Related Report
      2010 Final Research Report
  • [Presentation] Sample size determination in clinical trials with multiple co-primary binary endpoints2010

    • Author(s)
      Sozu T, Sugimoto T, Hamasaki T
    • Organizer
      The XXVth International Biometric Conference
    • Place of Presentation
      Florianopolis, Brazil
    • Year and Date
      2010-12-06
    • Related Report
      2010 Annual Research Report
  • [Presentation] 複数の主要評価変数をもつ臨床試験の症例数設計:正規変数と2値変数が存在する場合2010

    • Author(s)
      寒水孝司, 杉本知之, 濱崎俊光
    • Organizer
      日本計量生物学会
    • Place of Presentation
      統計数理研究所,東京
    • Year and Date
      2010-05-21
    • Related Report
      2010 Annual Research Report
  • [Presentation] Sample size determination in clinical trials with multiple co-primary binary endpoints.2010

    • Author(s)
      寒水孝司, 杉本知之, 濱崎俊光
    • Organizer
      The XXVth International Biometric Conference
    • Place of Presentation
      Florianopo-lis, Brazil
    • Related Report
      2010 Final Research Report
  • [Presentation] 複数の主要評価変数をもつ臨床試験の症例数設計:正規変数と2 値変数が存在する場合2010

    • Author(s)
      寒水孝司, 杉本知之, 濱崎俊光
    • Organizer
      日本計量生物学会・2010年度年会,講演予稿集,13-18
    • Place of Presentation
      統計数理研究所
    • Related Report
      2010 Final Research Report
  • [Presentation] Sample size determination in clinical trials with multiple co-primary binary endpoints.2009

    • Author(s)
      寒水孝司, 杉本知之, 濱崎俊光
    • Organizer
      US Food and Drug Administration
    • Place of Presentation
      (Invited Presentation)
    • Year and Date
      2009-12-11
    • Related Report
      2010 Final Research Report
  • [Presentation] 相関をもつ二つの変数の比に対する解析2009

    • Author(s)
      朝倉こう子, 上坂浩之, 杉本知之, 濱崎俊光
    • Organizer
      応用統計学会・2009年度年会予稿集,76-77
    • Place of Presentation
      統計数理研究所
    • Year and Date
      2009-08-01
    • Related Report
      2010 Final Research Report
  • [Presentation] 相関をもつ二つの変数の比に対する解析2009

    • Author(s)
      朝倉こう子, 他
    • Organizer
      応用統計学会
    • Place of Presentation
      東京
    • Year and Date
      2009-08-01
    • Related Report
      2009 Annual Research Report
  • [Presentation] Statistical issues in global clinical drug development with close look at Ja-pan and the Asian region.2009

    • Author(s)
      上坂浩之
    • Organizer
      The 57th Session of the International Statistical Institute
    • Place of Presentation
      Durban, South Africa
    • Related Report
      2010 Final Research Report
  • [Presentation] Sample size determination in clinical trials with multiple co-primary binary endpoints.2009

    • Author(s)
      寒水孝司, 杉本知之, 濱崎俊光
    • Organizer
      Joint Sta-tistical Meeting 2009
    • Place of Presentation
      Washington D.C.
    • Related Report
      2010 Final Research Report
  • [Presentation] An analysis of long-term censored data from a randomized withdrawal study in patients with major depressive disorder.2009

    • Author(s)
      Hamasaki T, Sugimoto T, Arano I.
    • Organizer
      The 8th Annual Ha-waii International Conference on Statistics, Ma-thematics and Related Fields
    • Place of Presentation
      Honolulu, Hawaii, USA
    • Related Report
      2010 Final Research Report
  • [Presentation] Power and sample size calculations in clinical trials with multiple co-primary binary variables2009

    • Author(s)
      Sozu, T., et al.
    • Organizer
      Joint Statistical Meeting
    • Place of Presentation
      Washington DC., USA
    • Related Report
      2009 Annual Research Report
  • [Presentation] Statistical issues in global clinical drug development with close look at Japan and the Asian region2009

    • Author(s)
      Uesaka, H.
    • Organizer
      The 57th session of the International Statistical Institute
    • Place of Presentation
      Durban, South Africa
    • Related Report
      2009 Annual Research Report
  • [Presentation] Professional and continuing education for biopharmaceutical statisticians2009

    • Author(s)
      Hamasaki, T.
    • Organizer
      International Drug Discovery, Science and Technology
    • Place of Presentation
      Shanghai, China
    • Related Report
      2009 Annual Research Report
  • [Presentation] An analysis of long-term censored data from a randomized withdrawal study in patients with maj or depressive disorder2009

    • Author(s)
      Hamasaki, T., et al.
    • Organizer
      8th Annual Hawaii International Conference on Statistics, Mathematics and Related Fields
    • Place of Presentation
      Honolulu, Hawaii, USA
    • Related Report
      2008 Annual Research Report
  • [Presentation] Professional and con-tinuing education for biostatisticians in Japan.2008

    • Author(s)
      濱崎俊光
    • Organizer
      The First Symposium on Biopharmaceutical Sta-tistics
    • Place of Presentation
      Shanghai, China(Invited Presentation)
    • Related Report
      2010 Final Research Report
  • [Presentation] Panel Discussion : Pre-paring the next generation of applied statistician : A global aspect.2008

    • Author(s)
      濱崎俊光
    • Organizer
      The First Symposium on Bio-pharmaceutical Statistics
    • Place of Presentation
      Shanghai, China(Invited Presentation)
    • Related Report
      2010 Final Research Report
  • [Presentation] Further analysis of randomized withdrawal stu-dies : An application of a Cox cure regression to a sertraline clinical study for patients with major depressive disorder.2008

    • Author(s)
      Arano I, Hamasaki T, Sugimoto T
    • Organizer
      Graybill Conference VII
    • Place of Presentation
      Fort Collins, Colorado, USA
    • Related Report
      2010 Final Research Report
  • [Presentation] Further analysis of randomized withdrawal studies : An application of a Cox cure regression to a sertraline clinical study for patients with major depressive disorder2008

    • Author(s)
      Arano, I., et al.
    • Organizer
      Graybill Conference VII
    • Place of Presentation
      Fort Collins, Colorado, USA
    • Related Report
      2008 Annual Research Report
  • [Presentation] Professional and continuing education for biostatisticians in Japan2008

    • Author(s)
      Kamasaki, T.
    • Organizer
      The First Symposium on Biopharmaceutical Statistics
    • Place of Presentation
      Shanghai, China
    • Related Report
      2008 Annual Research Report
  • [Presentation] Preparing the next generation of applied statistician : A global aspect2008

    • Author(s)
      Hamasaki, T.
    • Organizer
      The First Symposium on Biopharmaceutical Statistics
    • Place of Presentation
      Shanghai, China
    • Related Report
      2008 Annual Research Report
  • [Presentation] Preparing the next generation of applied statistician : A global aspect2008

    • Author(s)
      Sozu, T.
    • Organizer
      The 15th Biopharmaceutical Applied Statistics Symposium
    • Place of Presentation
      Savannah, Georgia, USA
    • Related Report
      2008 Annual Research Report
  • [Book] International Encyclopedia of Statistical Science(History of clinical trials.)(M. Lovric (Ed))vol.12011

    • Author(s)
      濱崎俊光
    • Publisher
      Berlin : Springer
    • Related Report
      2010 Final Research Report
  • [Book] International Encyclopedia of Statistical Science(Clinical trials : Overview.)(M. Lovric (Ed))vol.12011

    • Author(s)
      Uesaka H.
    • Publisher
      Berlin : Springer.
    • Related Report
      2010 Final Research Report
  • [Book] International Encyclopedia of Statistical Science Vol.1(History of Clinical Trials)2011

    • Author(s)
      Hamasaki T(共著)
    • Publisher
      Springer
    • Related Report
      2010 Annual Research Report
  • [Book] International Encyclopedia of Statistical Science Vol.1(Clinical Trials : An Overview)2011

    • Author(s)
      Uesaka H(共著)
    • Publisher
      Springer
    • Related Report
      2010 Annual Research Report
  • [Book] 臨床試験の統計的エッセンス2010

    • Author(s)
      濱崎俊光
    • Publisher
      大阪大学出版会
    • Related Report
      2010 Final Research Report
  • [Remarks] ホームページ等

    • URL

      http://www.medstat.med.osaka-u.ac.jp

    • Related Report
      2010 Final Research Report

URL: 

Published: 2008-04-01   Modified: 2016-04-21  

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