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Statistical frameworks for efficient decision-making in complex clinical trial designs

Research Project

Project/Area Number 26330038
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Statistical science
Research InstitutionOsaka University

Principal Investigator

Hamasaki Toshimitsu  大阪大学, 国際医工情報センター, 招へい教授 (40379243)

Co-Investigator(Kenkyū-buntansha) 杉本 知之  鹿児島大学, 理工学研究科, 教授 (70324829)
寒水 孝司  東京理科大学, 工学部, 准教授 (80408723)
高橋 佳苗  国立研究開発法人国立循環器病研究センター, 研究開発基盤センター, 研究員(任期付) (80726761)
Project Period (FY) 2014-04-01 – 2017-03-31
Project Status Completed (Fiscal Year 2016)
Budget Amount *help
¥4,810,000 (Direct Cost: ¥3,700,000、Indirect Cost: ¥1,110,000)
Fiscal Year 2016: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2015: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2014: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Keywords臨床試験 / 多重性 / 群逐次デザイン / 適応的デザイン / 多重エンドポイント / 統計科学 / 生存時間データ / 標本サイズ再計算 / 医薬品開発 / 予測バイオマーカ / エンリッチメントデザイン
Outline of Final Research Achievements

Many recent clinical trials for evaluating efficacy and safety of new interventions include multiple objectives, especially in medical product development. There are advantages of clinical trials with multiple objectives over trials with a single objective saving time and resources and more completely characterizing the intervention effects. However, such clinical trials require conducting a number of statistical tests and analyses associated with multiple objectives, and then, complex multiplicity or multiple testing problems occur. In this project, our team has conducted research on the design and analysis of such clinical trials, especially focusing on group-sequential and adaptive designs for clinical trials with multiple objectives, including design modification during trials

Report

(4 results)
  • 2016 Annual Research Report   Final Research Report ( PDF )
  • 2015 Research-status Report
  • 2014 Research-status Report
  • Research Products

    (54 results)

All 2017 2016 2015 2014 Other

All Int'l Joint Research (7 results) Journal Article (8 results) (of which Int'l Joint Research: 6 results,  Peer Reviewed: 8 results,  Acknowledgement Compliant: 6 results,  Open Access: 2 results) Presentation (36 results) (of which Int'l Joint Research: 20 results,  Invited: 13 results) Book (3 results)

  • [Int'l Joint Research] Harvard University(米国)

    • Related Report
      2016 Annual Research Report
  • [Int'l Joint Research] Medical University of Vienna(Austria)

    • Related Report
      2016 Annual Research Report
  • [Int'l Joint Research] National Health Research Insisiute(Taiwan)

    • Related Report
      2016 Annual Research Report
  • [Int'l Joint Research]

    • Related Report
      2016 Annual Research Report
  • [Int'l Joint Research] Harvard University(米国)

    • Related Report
      2015 Research-status Report
  • [Int'l Joint Research] Medical University of Vienna(Austria)

    • Related Report
      2015 Research-status Report
  • [Int'l Joint Research] National Health Research Institute/Institute of Statistical Science(Taiwan)

    • Related Report
      2015 Research-status Report
  • [Journal Article] Sizing clinical trials when comparing bivariate time-to-event outcomes2017

    • Author(s)
      Sugimoto T, Hamasaki T, Evans S.R., Sozu T.
    • Journal Title

      Statistics in Medicine

      Volume: 36 Issue: 9 Pages: 1363-1382

    • DOI

      10.1002/sim.7225

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed / Int'l Joint Research / Acknowledgement Compliant
  • [Journal Article] Interim evaluation of efficacy or futility in group-sequential trials with multiple co-primary endpoints2017

    • Author(s)
      Asakura K, Hamasaki T, Evans SR.
    • Journal Title

      Biometrical Journal

      Volume: 印刷中

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed / Int'l Joint Research / Acknowledgement Compliant
  • [Journal Article] Group-sequential three arm noninferiority clinical trials designs2016

    • Author(s)
      Ochiai T, Hamasaki T, Evans SR, Asakura K, Ohno Y
    • Journal Title

      Journal of Biopharmaceutical Statistics

      Volume: 99 Issue: 1 Pages: 99-99

    • DOI

      10.1080/10543406.2016.1148710

    • Related Report
      2016 Annual Research Report 2015 Research-status Report
    • Peer Reviewed / Int'l Joint Research / Acknowledgement Compliant
  • [Journal Article] Reducing unnecessary measurements in clinical trials with multiple primary endpoints2016

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

      Journal of Biopharmaceutical Statistics

      Volume: 26 Issue: 4 Pages: 631-643

    • DOI

      10.1080/10543406.2015.1052497

    • Related Report
      2016 Annual Research Report 2015 Research-status Report
    • Peer Reviewed / Int'l Joint Research / Acknowledgement Compliant
  • [Journal Article] Sample size considerations in clinical trials when comparing two interventions using multiple co-primary binary relative risk contrasts2015

    • Author(s)
      Ando Y, Hamasaki T, Evans S, Asakura K, Sugimoto T, Sozu T, Ohno, Y
    • Journal Title

      Statistics in Biopharmaceutical Research

      Volume: 7 Issue: 2 Pages: 81-94

    • DOI

      10.1080/19466315.2015.1006373

    • Related Report
      2015 Research-status Report 2014 Research-status Report
    • Peer Reviewed / Int'l Joint Research / Acknowledgement Compliant
  • [Journal Article] Group-sequential strategies in clinical trials with multiple co-primary outcomes2015

    • Author(s)
      Hamasaki H, Asakura K, Evans, SR, Sugimoto T, Sozu T
    • Journal Title

      Statistics in Biopharmaceutical Research

      Volume: 7 Issue: 1 Pages: 36-54

    • DOI

      10.1080/19466315.2014.1003090

    • NAID

      120005619770

    • Related Report
      2015 Research-status Report 2014 Research-status Report
    • Peer Reviewed
  • [Journal Article] Group-sequential designs when considering two binary outcomes as co-primary endpoints2015

    • Author(s)
      Asakura K, Hamasaki T, Evans S, Sugimoto T, Sozu T
    • Journal Title

      Applied Statistics in Biomedicine and Clinical Trials Design

      Volume: 14 Pages: 235-262

    • DOI

      10.1007/978-3-319-12694-4_14

    • ISBN
      9783319126937, 9783319126944
    • Related Report
      2015 Research-status Report 2014 Research-status Report
    • Peer Reviewed / Open Access / Int'l Joint Research / Acknowledgement Compliant
  • [Journal Article] Sample size determination in group-sequential clinical trials with two co-primary endpoints2014

    • Author(s)
      Asakura, K., Hamasaki, T., Sugimoto, T., Hayashi, K., Evans, S., Sozu T
    • Journal Title

      Statistics in Medicine

      Volume: (First published online) Issue: 17 Pages: 2897-2913

    • DOI

      10.1002/sim.6154

    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Open Access
  • [Presentation] Statistical monitoring of clinical trials with semi-competing risks outcomes2017

    • Author(s)
      Hamasaki T, Evans SR, Sugimoto T, Asakura K
    • Organizer
      ENAR 2017 Spring Meeting
    • Place of Presentation
      Washington DC, USA
    • Year and Date
      2017-03-12
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Interim evaluation of efficacy or futility in group-sequential clinical trials with multiple co-primary endpoints2016

    • Author(s)
      Hamasaki T
    • Organizer
      The 10th International Chinese Statistical Association International Conference
    • Place of Presentation
      Shanghai, China
    • Year and Date
      2016-12-19
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] Improving the Quality of Clinical Trials in Network for Clinical Stroke Trials2016

    • Author(s)
      Hamasaki T
    • Organizer
      New Trends in Clinical Trials
    • Place of Presentation
      Taipei, Taiwan
    • Year and Date
      2016-11-23
    • Related Report
      2016 Annual Research Report
    • Invited
  • [Presentation] Statistical monitoring of clinical trials with two event-time outcomes2016

    • Author(s)
      Hamasaki T
    • Organizer
      National Central University Graduate Institute of Statistics Seminor
    • Place of Presentation
      Taipei, Taiwan
    • Year and Date
      2016-11-22
    • Related Report
      2016 Annual Research Report
    • Invited
  • [Presentation] Early evaluation of efficacy in group-sequential clinical trials with two time-to-event outcome2016

    • Author(s)
      Hamasaki T, Sugimoto T, Asakura K, Evans SR
    • Organizer
      The 2016 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
    • Place of Presentation
      Washington DC, USA
    • Year and Date
      2016-09-28
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Improved group sequential clinical trial designs when comparing two interventions using two time-event outcomes2016

    • Author(s)
      Hamasaki T
    • Organizer
      The 2016 International Indian Statistical Association Conference on Statistics
    • Place of Presentation
      Corvaliis, Oregon, USA
    • Year and Date
      2016-08-18
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] Group-sequential clinical trials for comparing two interventions using two time-to-event outcomes2016

    • Author(s)
      Hamasaki T, Sugimoto T, Asakura K, Evans SR
    • Organizer
      Joint Statistical Meetings 2016
    • Place of Presentation
      Chicago, USA
    • Year and Date
      2016-07-30
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Improved group sequential clinical trial designs with multiple co-primary endpoints2016

    • Author(s)
      Asakura K, Hamasaki T, Koenig F, Posch M
    • Organizer
      Joint Statistical Meetings 2016
    • Place of Presentation
      Chicago, USA
    • Year and Date
      2016-07-30
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Interim evaluation of efficacy or futility in group-sequential trials with multiple co-primary endpoints2016

    • Author(s)
      Hamasaki T
    • Organizer
      The 25th South Taiwan Statistics Conference
    • Place of Presentation
      Kaohsiung, Taiwan,
    • Year and Date
      2016-06-24
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] Group-sequential three-arm noninferiority clinical trial designs2016

    • Author(s)
      Hamasaki T, Ochiai T, Evans SR, Asakura K, Fukuda M, Yamamoto H
    • Organizer
      The 37th Annual Meeting of the Society for Clinical Trials
    • Place of Presentation
      Montreal, Canada
    • Year and Date
      2016-05-15
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Interim monitoring of clinical trials with co-primary endpoints using predicted intervals2016

    • Author(s)
      21.Asakura K, Hamasaki T, Evans SR, Hsiao CF, Fukuda M, Yamamoto H
    • Organizer
      The 37th Annual Meeting of the Society for Clinical Trials
    • Place of Presentation
      Montreal, Canada
    • Year and Date
      2016-05-15
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Sample size determination in clinical trials with two time-to-event outcomes2016

    • Author(s)
      Hamasaki T, Sugimoto T, Evans SR, Sozu T.
    • Organizer
      DIA/FDA Statistics 2016 Forum
    • Place of Presentation
      Bethesda, MD, USA
    • Year and Date
      2016-04-25
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Sizing clinical trials when comparing two interventions using two time-to-event outcomes2015

    • Author(s)
      Hamasaki T
    • Organizer
      WBS Herbstseminar 2015 "Advances in Trial Design", Wiener Biometrische Sektion (WBS) der Internationalen Biometrischen Gesellschaft Region esterreich-Schweiz (ROeS)
    • Place of Presentation
      Vienna, Austria
    • Year and Date
      2015-10-07
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Early stopping for futility or efficacy in group sequential clinical trials with multiple co-primary endpoints2015

    • Author(s)
      Hamasaki T, Asakura K, Evans SR
    • Organizer
      The 9th International Conference on Multiple Comparison Procedures
    • Place of Presentation
      Hyderabad, India
    • Year and Date
      2015-09-02
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] Sizing clinical trials when comparing two interventions using two time-to-event outcomes2015

    • Author(s)
      Sugimoto T, Hamasaki T, Evans SR, Sozu T
    • Organizer
      Joint Statistical Meetings 2015
    • Place of Presentation
      Seattle, USA
    • Year and Date
      2015-08-08
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] Early stopping for futility or efficacy in group-sequential clinical trials with multiple co-primary endpoints2015

    • Author(s)
      Asakura K, Hamasaki T, Evans SR
    • Organizer
      Joint Statistical Meetings 2015
    • Place of Presentation
      Seattle, USA
    • Year and Date
      2015-08-08
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] Group-sequential strategies for clinical trials when comparing two interventions using multiple co-primary endpoints2015

    • Author(s)
      Hamasaki T, Asakura K, Evans SR
    • Organizer
      Joint Statistical Meetings 2015
    • Place of Presentation
      Seattle, USA
    • Year and Date
      2015-08-08
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] Group-sequential strategies for clinical trials when considering multiple endpoints as co-primary2015

    • Author(s)
      Hamasaki T, Asakura K, Evans SR
    • Organizer
      The ISBS/DIA Symposium on Biopharmaceutical Statistics
    • Place of Presentation
      Beijing, China
    • Year and Date
      2015-06-29
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Early stopping for futility or efficacy in group-sequential clinical trials with multiple co-primary endpoints2015

    • Author(s)
      Hamasaki T, Asakura K, Evans SR
    • Organizer
      The ISBS/DIA Symposium on Biopharmaceutical Statistics
    • Place of Presentation
      Beijing, China
    • Year and Date
      2015-06-29
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] Group-sequential strategies for clinical trials with multiple endpoints2015

    • Author(s)
      Hamasaki T, Evans SR, Asakura K
    • Organizer
      The Joint 24th ICSA Applied Statistics Symposium and 13th Graybill Conference
    • Place of Presentation
      Fort Collins, Colorado, USA
    • Year and Date
      2015-06-14
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] roup-sequential strategies for clinical trials with co-primary endpoints2015

    • Author(s)
      Asakura K, Hamasaki T, Evans SR, Fukuda M, Yamamoto H
    • Organizer
      The 36th Annual Meeting of the Society for Clinical Trials
    • Place of Presentation
      Arlington, Virginia, USA
    • Year and Date
      2015-05-17
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] Sample size considerations for clinical trials with two primary time-to-event outcomes2015

    • Author(s)
      Hamasaki T, Sugimoto T, Asakura K, Evans SR, Fukuda M, Yamamoto H
    • Organizer
      The 36th Annual Meeting of the Society for Clinical Trials
    • Place of Presentation
      Arlington, Virginia, USA
    • Year and Date
      2015-05-17
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] Designing and monitoring clinical trials when considering multiple outcomes as co-primary endpoints2015

    • Author(s)
      Hamasaki T, Sugimoto T, Sozu T.
    • Organizer
      Austria-Japan Joint Statistics Workshop
    • Place of Presentation
      Osaka, Japan
    • Year and Date
      2015-03-23 – 2015-03-27
    • Related Report
      2014 Research-status Report
    • Invited
  • [Presentation] Group-sequential strategies for clinical trials with multiple co-primary endpoints.2015

    • Author(s)
      Hamasaki T
    • Organizer
      Austria-Japan Joint Statistics Workshop
    • Place of Presentation
      Osaka, Japan
    • Year and Date
      2015-03-23 – 2015-03-27
    • Related Report
      2014 Research-status Report
    • Invited
  • [Presentation] Group-sequential strategies for clinical trials with multiple co-primary endpoints2014

    • Author(s)
      Hamasaki T
    • Organizer
      The Joint Meeting of National Health Research Institute with National Cerebral and Cardiovascular Center and Yonsei University
    • Place of Presentation
      National Health Research Institute, Taiwan
    • Year and Date
      2014-12-17 – 2014-12-18
    • Related Report
      2014 Research-status Report
    • Invited
  • [Presentation] Group-sequential strategies when considering multiple outcomes as co-primary in clinical trials2014

    • Author(s)
      Hamasaki T, Asakura K, Evans SR
    • Organizer
      The 35th Annual Conference of the International Society for Clinical Biostatistics
    • Place of Presentation
      Vienna, Austria
    • Year and Date
      2014-08-24 – 2014-08-28
    • Related Report
      2014 Research-status Report
  • [Presentation] Mid-course sample size modification in group-sequential designs for three-arm non-inferiority clinical trials2014

    • Author(s)
      Ochiai T, Ohno Y, Hamasaki T.
    • Organizer
      Joint Statistical Meetings 2014
    • Place of Presentation
      Boston, USA
    • Year and Date
      2014-08-02 – 2014-08-07
    • Related Report
      2014 Research-status Report
  • [Presentation] A comparison of multiple testing procedures that compare two interventions with respect to two time-to-event outcomes in clinical trials2014

    • Author(s)
      191.Ando Y, Hamasaki T, Sugimoto T, Asakura K, Ohno Y.
    • Organizer
      Joint Statistical Meetings 2014
    • Place of Presentation
      Boston, USA
    • Year and Date
      2014-08-02 – 2014-08-07
    • Related Report
      2014 Research-status Report
  • [Presentation] Group-sequential strategies when considering multiple binary outcomes as co-primary endpoints2014

    • Author(s)
      Hamasaki T, Asakura K, Evans SR
    • Organizer
      Joint Statistical Meetings 2014
    • Place of Presentation
      Boston, USA
    • Year and Date
      2014-08-02 – 2014-08-07
    • Related Report
      2014 Research-status Report
  • [Presentation] A practical comparison of restricted and covariate-adaptive methods for treatment allocation in clinical trials2014

    • Author(s)
      Takahashi K, Hamasaki T, Asakura K, Yamamoto H.
    • Organizer
      The XXVII International Biometric Conference
    • Place of Presentation
      Florence, Italy
    • Year and Date
      2014-07-05 – 2014-07-11
    • Related Report
      2014 Research-status Report
  • [Presentation] A cost-effective clinical trial design with multiple primary endpoints2014

    • Author(s)
      Sozu T, Sugimoto T, Hamasaki T.
    • Organizer
      The XXVII International Biometric Conference
    • Place of Presentation
      Florence, Italy
    • Year and Date
      2014-07-05 – 2014-07-11
    • Related Report
      2014 Research-status Report
  • [Presentation] Group-sequential designs for clinical trials with multiple co-primary endpoints2014

    • Author(s)
      Asakura K, Hamasaki T, Evans S.
    • Organizer
      The 3rd Institute of Mathematical Statistics Asia Pacific Rim Meeting
    • Place of Presentation
      Taipei, Taiwan
    • Year and Date
      2014-06-29 – 2014-07-02
    • Related Report
      2014 Research-status Report
  • [Presentation] Multiple comparison procedures when considering two time-to-event outcomes as primary contrasts in clinical trials2014

    • Author(s)
      Ando Y, Hamasaki T, Ohno Y.
    • Organizer
      The 3rd Institute of Mathematical Statistics Asia Pacific Rim Meeting
    • Place of Presentation
      Taipei, Taiwan
    • Year and Date
      2014-06-29 – 2014-07-02
    • Related Report
      2014 Research-status Report
  • [Presentation] Group-sequential designs for clinical trials with multiple co-primary endpoints2014

    • Author(s)
      Hamasaki T.
    • Organizer
      The 23rd South Taiwan Statistics Conference and 2014 Chinese Institute of Probability and Statistics Annual Meeting
    • Place of Presentation
      National Dong Hwa University, Hualien, Taiwan
    • Year and Date
      2014-06-23 – 2014-06-24
    • Related Report
      2014 Research-status Report
    • Invited
  • [Presentation] Designing and monitoring group-sequential clinical trials with multiple co-primary endpoints2014

    • Author(s)
      Asakura K, Hamasaki T, Evans SR, Yamamoto H.
    • Organizer
      The 35th Annual Meeting of Society for Clinical Trials
    • Place of Presentation
      Philadelphia, Pennsylvania, USA
    • Year and Date
      2014-05-18 – 2014-05-21
    • Related Report
      2014 Research-status Report
  • [Presentation] An e-mail based system for patient registration and treatment randomization with the application to a real randomized controlled trial2014

    • Author(s)
      Takahashi K, Hamasaki T, Yamamoto H.
    • Organizer
      The 35th Annual Meeting of Society for Clinical Trials
    • Place of Presentation
      Philadelphia, Pennsylvania, USA
    • Year and Date
      2014-05-18 – 2014-05-21
    • Related Report
      2014 Research-status Report
  • [Book] Group-Sequential Clinical Trials with Multiple Co-Objectives2016

    • Author(s)
      Hamasaki T, Asakura K, Ochiai T, Evans SR
    • Total Pages
      113
    • Publisher
      Springer
    • Related Report
      2016 Annual Research Report
  • [Book] Group-Sequential Clinical Trials with Multiple Co-Objectives2016

    • Author(s)
      Hamasaki T, Asakura K, Evans SR, Ochiai T
    • Total Pages
      108
    • Publisher
      Springer
    • Related Report
      2015 Research-status Report
  • [Book] Sample Size Determination in Clinical Trials with Multiple Endpoints2015

    • Author(s)
      ozu T, Sugimoto T, Hamasaki T, Evans SR
    • Total Pages
      98
    • Publisher
      Springer
    • Related Report
      2015 Research-status Report

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Published: 2014-04-04   Modified: 2022-02-28  

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