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Bayesian study designs for new drug development in early-stage cancer clinical trials.

Research Project

Project/Area Number 24500345
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Statistical science
Research InstitutionKyoto University (2013-2014)
Yokohama City University (2012)

Principal Investigator

MORITA Satoshi  京都大学, 医学(系)研究科(研究院), 教授 (60362480)

Co-Investigator(Kenkyū-buntansha) DAIMON Takashi  兵庫医科大学, 教授 (40372156)
TERAMUKAI Satoshi  京都府立医科大学, 教授 (20359798)
TOI Masakazu  京都大学, 大学院医学研究科, 教授 (10207516)
Research Collaborator THALL Peter F.  University of Texas M.D. Anderson Cancer Center, 教授
Project Period (FY) 2012-04-01 – 2015-03-31
Project Status Completed (Fiscal Year 2014)
Budget Amount *help
¥5,330,000 (Direct Cost: ¥4,100,000、Indirect Cost: ¥1,230,000)
Fiscal Year 2014: ¥2,600,000 (Direct Cost: ¥2,000,000、Indirect Cost: ¥600,000)
Fiscal Year 2013: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2012: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Keywordsバイオマーカー / 個別化医療 / ベイズ流統計学 / 臨床腫瘍学
Outline of Final Research Achievements

We have developed novel study designs for phase I and phase II clinical trials aiming to boost new drug developments. We have proposed a new statistical approach to appropriately combine historical data into a current phase I clinical trial in which the safety of a new study treatment is evaluated. In addition, we have proposed to integrate biomarker data to design a phase II clinical trial to efficiently develop a stratified therapy. We will use our proposed methods in actual clinical trials.

Report

(4 results)
  • 2014 Annual Research Report   Final Research Report ( PDF )
  • 2013 Research-status Report
  • 2012 Research-status Report
  • Research Products

    (9 results)

All 2015 2014 2013 Other

All Journal Article (4 results) (of which Peer Reviewed: 4 results,  Acknowledgement Compliant: 1 results) Presentation (5 results)

  • [Journal Article] Incorporating historical data in Bayesian phase I trial design: The Caucasian-to-Asian toxicity tolerability problem.2015

    • Author(s)
      Takeda K, Morita S.
    • Journal Title

      Therapeutic Innovation & Regulatory Science

      Volume: 49 Issue: 1 Pages: 93-99

    • DOI

      10.1177/2168479014546333

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Biomarker-based Bayesian randomized phase II clinical trial design to identify a sensitive patient subpopulation2014

    • Author(s)
      Morita S. Yamamoto H, Sugitani Y
    • Journal Title

      Stat Med

      Volume: 33 Issue: 23 Pages: 4008-4018

    • DOI

      10.1002/sim.6209

    • NAID

      120005669352

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Exploring ethnic differences in toxicity in early phase clinical trials for oncology drugs2014

    • Author(s)
      Ogura T, Morita S, Yonemori K, Nonaka T, Urano T
    • Journal Title

      Therapeutic Innovation & Regulatory Science

      Volume: 48 Issue: 5 Pages: 644-650

    • DOI

      10.1177/2168479014524582

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed
  • [Journal Article] A continual reassessment method with cohort size adaptation based on Bayesian posterior probabilities in phase I dose-finding studies2014

    • Author(s)
      Kakizume T, Morita S
    • Journal Title

      Therapeutic Innovation & Regulatory Science

      Volume: 48 Issue: 2 Pages: 213-219

    • DOI

      10.1177/2168479013500970

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed
  • [Presentation] Practical use of modified continual reassessment method with prior distribution weighted by effective sample size for a phase I dose-finding study in a new region.2013

    • Author(s)
      Takeda K, Morita S.
    • Organizer
      The 34th Annual Conference of the International Society for Clinical Biostatistics
    • Place of Presentation
      Munich, Germany
    • Related Report
      2013 Research-status Report
  • [Presentation] Incorporating historical data in Bayesian phase I trial design: The Caucasian-to-Asian toxicity tolerability problem.

    • Author(s)
      Morita S.
    • Organizer
      The Ninth ICSA International Conference
    • Place of Presentation
      Hong Kong
    • Related Report
      2013 Research-status Report
  • [Presentation] An extension of the continual reassessment method with adjustable cohort size based on Bayesian posterior probabilities in cancer phase I studies.

    • Author(s)
      Kakizume T, Morita S.
    • Organizer
      The 34th Annual Conference of the International Society for Clinical Biostatistics
    • Place of Presentation
      Munich, Germany
    • Related Report
      2013 Research-status Report
  • [Presentation] Bayesian study designs for new drug development.

    • Author(s)
      Morita S.
    • Organizer
      ISBA 2012 World Meeting,
    • Place of Presentation
      Kyoto, Japan
    • Related Report
      2012 Research-status Report
  • [Presentation] Bridging dose-finding for a multinational cancer phase I trial.

    • Author(s)
      Morita S
    • Organizer
      Society for Clinical Trials 34th Annual Meeting
    • Place of Presentation
      BOSTON, MASSACHUSETTS, USA
    • Related Report
      2012 Research-status Report

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Published: 2013-05-31   Modified: 2019-07-29  

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