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Development of medical technology assessment methodology based on Bayesian statistics

Research Project

Project/Area Number 22500257
Research Category

Grant-in-Aid for Scientific Research (C)

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

Principal Investigator

TERAMUKAI Satoshi  京都大学, 医学研究科, 准教授 (20359798)

Research Collaborator DAIMON Takashi  兵庫医科大学, 医学部, 准教授 (40372156)
Project Period (FY) 2010 – 2012
Project Status Completed (Fiscal Year 2012)
Budget Amount *help
¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Fiscal Year 2012: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2011: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2010: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Keywords医薬生物・ゲノム統計解析 / ベイズ統計学 / 医薬生物 / 統計解析 / 臨床試験
Research Abstract

Since 1950s in which the methodology of clinical trials was established, significance tests and estimation have dominated as standard approaches. This approach is called frequentist approach. In recent years, Bayesian statistics have been applied to compl ex stati stical modeling in biomedical field and several approaches to study design and sequential monitoring have been proposed mainly in cancer clinical trials . We developed new design for exploratory clinical trials based on Bayesian approach.

Report

(4 results)
  • 2012 Annual Research Report   Final Research Report ( PDF )
  • 2011 Annual Research Report
  • 2010 Annual Research Report
  • Research Products

    (31 results)

All 2013 2012 2011 2010 Other

All Journal Article (5 results) (of which Peer Reviewed: 1 results) Presentation (23 results) Book (1 results) Remarks (2 results)

  • [Journal Article] 京都大学における臨床試験支援-データセンターの機能と役割2013

    • Author(s)
      手良向聡
    • Journal Title

      医学のあゆみ

      Volume: 244 Pages: 1148-1153

    • Related Report
      2012 Annual Research Report
  • [Journal Article] A Bayesian predictive sample size selection design for single-arm exploratory clinical trials2012

    • Author(s)
      Teramukai S, DaimonT, ZoharS
    • Journal Title

      Statistics in Medicine

      Volume: 31 Issue: 30 Pages: 4243-4254

    • DOI

      10.1002/sim.5505

    • Related Report
      2012 Annual Research Report 2012 Final Research Report
    • Peer Reviewed
  • [Journal Article] 臨床試験論文の読み方2011

    • Author(s)
      手良向聡
    • Journal Title

      臨床血液

      Volume: 52 Pages: 1696-1701

    • NAID

      10029769613

    • Related Report
      2011 Annual Research Report
  • [Journal Article] 産業界およびFDAスタッフのためのガイダンス「医療機器の臨床試験におけるBayes統計学の利用に関するガイダンス」2010

    • Author(s)
      手良向聡、大門貴志訳
    • Journal Title

      臨床評価

      Volume: 38 Pages: 291-326

    • Related Report
      2010 Annual Research Report
  • [Journal Article] FDA「医療機器の臨床試験におけるBayes統計学の利用に関するガイダンス」について2010

    • Author(s)
      手良向聡、大門貴志
    • Journal Title

      臨床評価

      Volume: 38 Pages: 327-334

    • Related Report
      2010 Annual Research Report
  • [Presentation] 単群探索的臨床試験におけるベイズ流予測標本サイズ選択デザイン.医学統計研究会特定主題シンポジウム2013

    • Author(s)
      手良向聡
    • Organizer
      2013「臨床試験における適応型計画を再考する」
    • Place of Presentation
      東京
    • Year and Date
      2013-02-02
    • Related Report
      2012 Final Research Report
  • [Presentation] 期待奏効確率の不確実性を考慮した第II相単群ベイズ流適応型デザイン2012

    • Author(s)
      手良向聡、大門貴志
    • Organizer
      第50回日本癌治療学会学術集会
    • Place of Presentation
      横浜
    • Year and Date
      2012-10-26
    • Related Report
      2012 Final Research Report
  • [Presentation] A Bayesian predictive sample size selection design for single-arm exploratory clinical trials2012

    • Author(s)
      Teramukai S, Daimon T, Zohar
    • Organizer
      International Society for Bayesian Analysis 2012 World Meeting
    • Place of Presentation
      Kyoto
    • Year and Date
      2012-06-28
    • Related Report
      2012 Final Research Report
  • [Presentation] Bayes流臨床試験デザイン2012

    • Author(s)
      手良向聡
    • Organizer
      第3回日本臨床試験研究会
    • Place of Presentation
      福岡
    • Year and Date
      2012-03-23
    • Related Report
      2012 Final Research Report
  • [Presentation] 代替エンドポイントの統計学的評価2012

    • Author(s)
      手良向聡
    • Organizer
      橋渡し研究支援推進プログラム平成23年度成果報告会
    • Place of Presentation
      ベルサール汐留(東京都)(招待講演)
    • Year and Date
      2012-03-03
    • Related Report
      2011 Annual Research Report
  • [Presentation] Bayes流臨床試験デザイン2012

    • Author(s)
      手良向聡
    • Organizer
      第3回日本臨床試験研究会
    • Place of Presentation
      福岡国際会議場(招待講演)
    • Year and Date
      2012-02-23
    • Related Report
      2011 Annual Research Report
  • [Presentation] Bayesian design in exploratory clinical trials2012

    • Author(s)
      Teramukai S
    • Organizer
      The 3rd East Asia Regional Biometric Conference 2012
    • Place of Presentation
      Seoul, Korea
    • Year and Date
      2012-02-03
    • Related Report
      2012 Final Research Report
  • [Presentation] Bayesian design in exploratory clinical trialsclinical trials2012

    • Author(s)
      Teramukai S
    • Organizer
      The 3rd East Asia Regional Biometric Conference 2012
    • Place of Presentation
      ソウル(韓国)(Invited Session)
    • Year and Date
      2012-02-03
    • Related Report
      2011 Annual Research Report
  • [Presentation] 大学における医師主導型治験・臨床試験とその実施体制2011

    • Author(s)
      手良向聡
    • Organizer
      第49回日本癌治療学会学術集会
    • Place of Presentation
      名古屋国際会議場(招待講演)
    • Year and Date
      2011-10-27
    • Related Report
      2011 Annual Research Report
  • [Presentation] 臨床統計学のABC:メタアナリシス入門2011

    • Author(s)
      手良向聡
    • Organizer
      第34回日本高血圧学会総会
    • Place of Presentation
      栃木県総合文化センター(教育講演)
    • Year and Date
      2011-10-20
    • Related Report
      2011 Annual Research Report
  • [Presentation] 臨床試験論文の読み方2011

    • Author(s)
      手良向聡
    • Organizer
      第73回日本血液学会学術集会
    • Place of Presentation
      名古屋国際会議場(教育講演)
    • Year and Date
      2011-10-14
    • Related Report
      2011 Annual Research Report
  • [Presentation] A Bayesian adaptive design with two-priors approach and predictive probabilities in single-arm exploratory clinical trials2011

    • Author(s)
      Teramukai S, DaimonT, ZoharS
    • Organizer
      32nd annual conference of the International Society of Clinical Biostatistics
    • Place of Presentation
      Ottawa, Canada
    • Year and Date
      2011-08-23
    • Related Report
      2012 Final Research Report
  • [Presentation] A Bayesian adaptive design with two-priors approach and predictive probabilities in single-arm exploratory clinical trials2011

    • Author(s)
      Teramukai S, Daimon T, Zohar S
    • Organizer
      International Society of Clinical Biostatistics
    • Place of Presentation
      オタワ(カナダ)
    • Year and Date
      2011-08-23
    • Related Report
      2011 Annual Research Report
  • [Presentation] 探索的臨床試験のデザインにおけるBayes流統計学の利用2011

    • Author(s)
      手良向聡
    • Organizer
      日本薬学会第131年会
    • Place of Presentation
      紙上発表(学会中止のため)(招待)
    • Year and Date
      2011-03-31
    • Related Report
      2010 Annual Research Report
  • [Presentation] 高度医療評価制度下での臨床試験の計画・解析におけるベイズ法の有用性2011

    • Author(s)
      吉村健一、手良向聡、小林博人、田中司朗、池田隆文、清水章、川上浩司
    • Organizer
      第21回日本疫学会 学術総会
    • Place of Presentation
      札幌市(かでる2.7)
    • Year and Date
      2011-01-21
    • Related Report
      2010 Annual Research Report
  • [Presentation] 探索的臨床試験におけるBayes流デザイン2011

    • Author(s)
      手良向聡
    • Organizer
      科研費シンポジウム「医薬品の研究開発における新しい統計的課題と挑戦」
    • Place of Presentation
      大阪
    • Year and Date
      2011-01-18
    • Related Report
      2012 Final Research Report
  • [Presentation] 探索的臨床試験におけるBayes流デザイン2011

    • Author(s)
      手良向聡
    • Organizer
      科研費シンポジウム「医薬品の研究開発における新しい統計的課題と挑戦」
    • Place of Presentation
      大阪市(大阪大学中之島センター)(招待)
    • Year and Date
      2011-01-18
    • Related Report
      2010 Annual Research Report
  • [Presentation] 科学的実験と統計的実験の境界2010

    • Author(s)
      手良向聡
    • Organizer
      日本分子生物学会若手教育シンポジウム
    • Place of Presentation
      神戸市(神戸国際会議場)(招待)
    • Year and Date
      2010-12-08
    • Related Report
      2010 Annual Research Report
  • [Presentation] 高度医療評価制度の下でのベイズ流臨床試験デザインの応用とそのデザイン特性2010

    • Author(s)
      吉村健一、手良向聡、小林博人、田中司朗、池田隆文、清水章、川上浩司
    • Organizer
      第48回日本癌治療学会学術集会
    • Place of Presentation
      京都市(国立京都国際会館)
    • Year and Date
      2010-10-30
    • Related Report
      2010 Annual Research Report
  • [Presentation] ベイズ流標本サイズ決定におけるdesign priorの意義2010

    • Author(s)
      手良向聡
    • Organizer
      2010年度統計関連学会連合大会
    • Place of Presentation
      東京
    • Year and Date
      2010-09-06
    • Related Report
      2012 Final Research Report
  • [Presentation] ベイズ流標本サイズ決定におけるdesign priorの意義2010

    • Author(s)
      手良向聡
    • Organizer
      2010年度統計関連学会連合大会
    • Place of Presentation
      東京都(早稲田大学)
    • Year and Date
      2010-09-06
    • Related Report
      2010 Annual Research Report
  • [Presentation] A Bayesian predictive sample size selection design for single-arm exploratory clinical trials

    • Author(s)
      Teramukai S.
    • Organizer
      International Society for Bayesian Analysis 2012 World Meeting
    • Place of Presentation
      京都テルサ
    • Related Report
      2012 Annual Research Report
  • [Presentation] 期待奏効割合の不確実性を考慮したベイズ流第II相単群適応型デザイン

    • Author(s)
      手良向聡
    • Organizer
      第50回日本癌治療学会学術集会
    • Place of Presentation
      パシフィコ横浜
    • Related Report
      2012 Annual Research Report
  • [Book] 臨床試験の統計的デザイン.In:川上浩司編.遺伝子医学MOOK別冊はじめての臨床応用研究.2010

    • Author(s)
      手良向聡
    • Publisher
      メディカルドゥ社
    • Related Report
      2010 Annual Research Report
  • [Remarks]

    • URL

      http://www.kutrc.org

    • Related Report
      2011 Annual Research Report
  • [Remarks]

    • Related Report
      2010 Annual Research Report

URL: 

Published: 2010-08-23   Modified: 2019-07-29  

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