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Development of statistical design for small clinical trials

Research Project

Project/Area Number 26330037
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Statistical science
Research InstitutionKyoto Prefectural University of Medicine

Principal Investigator

Teramukai Satoshi  京都府立医科大学, 医学(系)研究科(研究院), 教授 (20359798)

Co-Investigator(Renkei-kenkyūsha) DAIMON Takashi  兵庫医科大学, 医学部, 教授 (40372156)
YOSHIMURA Kenichi  金沢大学附属病院, 特任教授 (30415517)
Project Period (FY) 2014-04-01 – 2018-03-31
Project Status Completed (Fiscal Year 2017)
Budget Amount *help
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2016: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2015: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2014: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Keywords臨床試験デザイン / ベイズ流統計学 / 適応的デザイン / 標本サイズ設定 / 中間モニタリング / 標本サイズ再設定
Outline of Final Research Achievements

(1) We proposed an extension of a Bayesian adaptive design denoted by the PSSD (predictive sample size selection design), to monitor efficacy, adapt the sample size during the trial and add continuous monitoring safety (Teramukai S, et al. Statistics in Medicine, 2015;34:3029-3039). (2) I published a textbook for introducing the Bayesian clinical trial design (Teramukai S. Naze Bayes-wo tsukawanainoka? Kinpodo, 2017). (3) We reviewed the basket trial design and proposed the new Bayesian design using the similarity measure among posterior distributions (Teramukai S, et al. Japan Society of Clinical Trials and Research, the 9th Annual Meeting, 2018). (4) We applied the PSSD to the phase II clinical trials for high risk rhabdomyosarcoma patients, sponsored by JCCG (Japan Children’s Cancer Group).

Report

(5 results)
  • 2017 Annual Research Report   Final Research Report ( PDF )
  • 2016 Research-status Report
  • 2015 Research-status Report
  • 2014 Research-status Report
  • Research Products

    (14 results)

All 2018 2017 2016 2015 2014 Other

All Int'l Joint Research (1 results) Journal Article (3 results) (of which Int'l Joint Research: 1 results,  Peer Reviewed: 3 results,  Open Access: 2 results) Presentation (6 results) (of which Int'l Joint Research: 2 results,  Invited: 3 results) Book (2 results) Remarks (1 results) Funded Workshop (1 results)

  • [Int'l Joint Research] INSERM U1138(France)

    • Related Report
      2015 Research-status Report
  • [Journal Article] A multicenter phase II study of salvage photodynamic therapy using talaporfin sodium (ME2906) and a diode laser (PNL6405EPG) for local failure after chemoradiotherapy or radiotherapy for esophageal cancer.2017

    • Author(s)
      Yano T, Kasai H, Horimatsu T, Yoshimura K, Teramukai S, Morita S, Tada H, Yamamoto Y, Kataoka H, Kakushima N, Ishihara R, Isomoto H, Muto M.
    • Journal Title

      Oncotarget

      Volume: 8 Issue: 13 Pages: 22135-22144

    • DOI

      10.18632/oncotarget.14029

    • NAID

      120006360782

    • Related Report
      2016 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] An extension of Bayesian predictive sample size selection designs for monitoring efficacy and safety.2015

    • Author(s)
      Teramukai S, Daimon T, Zohar S.
    • Journal Title

      Statistics in Medicine

      Volume: 34 Issue: 22 Pages: 3029-3039

    • DOI

      10.1002/sim.6550

    • Related Report
      2015 Research-status Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Effects of zoledronic acid and the association between its efficacy and \gamma\delta T cells in postmenopausal women with breast cancer treated with preoperative hormonal therapy: a study protocol2014

    • Author(s)
      Sumi E, Sugie T, Yoshimura K, Tada H, Ikeda T, Suzuki E, Tanaka Y, Teramukai S, Shimizu A, Toi M, Minato N
    • Journal Title

      Journal of Translational Medicine

      Volume: 12 Issue: 1 Pages: 310-310

    • DOI

      10.1186/s12967-014-0310-2

    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Open Access
  • [Presentation] 事後分布の類似度に基づいて他の層から借りる情報の量を決めるベイズ流バスケット試験デザイン2018

    • Author(s)
      手良向聡、藤川桂、横田勲、大門貴志
    • Organizer
      日本臨床試験学会 第9回学術集会総会
    • Related Report
      2017 Annual Research Report
  • [Presentation] ベイズ流意思決定の基本的考え方2017

    • Author(s)
      手良向聡
    • Organizer
      第15回日本臨床腫瘍学会学術集会
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] ベイズ流臨床試験デザイン2017

    • Author(s)
      手良向聡
    • Organizer
      2017年度統計関連学会連合大会企画セッション
    • Related Report
      2017 Annual Research Report
  • [Presentation] Comparison of sequential clinical trial designs with time-to-event outcomes in small populations.2016

    • Author(s)
      Yokota I, Kashiwabara K, Sakamaki K, Teramukai S.
    • Organizer
      XXVIIIth International Biometric Conference
    • Place of Presentation
      Victoria, Canada
    • Year and Date
      2016-07-10
    • Related Report
      2016 Research-status Report
    • Int'l Joint Research
  • [Presentation] Bayesian phase II designs2015

    • Author(s)
      Teramukai S
    • Organizer
      Pacific Rim Cancer Biostatistics Workshop
    • Place of Presentation
      Seattle, USA
    • Year and Date
      2015-08-14
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] ベイズ流標本サイズ設定2015

    • Author(s)
      手良向聡
    • Organizer
      医学統計研究会特定主題シンポジウム2015「臨床評価におけるBayes流接近法」
    • Place of Presentation
      東京
    • Year and Date
      2015-02-07
    • Related Report
      2014 Research-status Report
    • Invited
  • [Book] なぜベイズを使わないのか!?2017

    • Author(s)
      手良向聡
    • Total Pages
      162
    • Publisher
      金芳堂
    • ISBN
      9784765317238
    • Related Report
      2017 Annual Research Report
  • [Book] 臨床試験デザイン-ベイズ流・頻度流の適応的方法2014

    • Author(s)
      手良向聡、大門貴志訳
    • Total Pages
      345
    • Publisher
      メディカル・パブリケーションズ
    • Related Report
      2014 Research-status Report
  • [Remarks] 京都府立医科大学大学院医学研究科生物統計学

    • URL

      http://www.f.kpu-m.ac.jp/k/biostat/

    • Related Report
      2016 Research-status Report
  • [Funded Workshop] 4th Clinical Trial Design (CTD) Conference2017

    • Place of Presentation
      Kyoto, Japan
    • Related Report
      2016 Research-status Report

URL: 

Published: 2014-04-04   Modified: 2019-03-29  

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