Statistical research on the design of clinical trials where the quantitative balance of benefits and risks is taken into account.

• Project/Area Number: 20500267
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Statistical science
• Research Institution: National Institute of Public Health
• Principal Investigator: NISHIKAWA Masako National Institute of Public Health, 技術評価部, 統計高度利用室長 (50373395)
• Co-Investigator(Renkei-kenkyūsha): TANGO Toshiro 昭和女子大学, 大学院・生活機構研究科, 客員教授 (70124477) ; HIDA Eisuke 国立保健医療科学院, 技術評価部, 主任研究官 (30469952)
• Project Period (FY): 2008 – 2010
• Project Status: Completed (Fiscal Year 2010)
• Budget Amount: ¥4,420,000 (Direct Cost: ¥3,400,000、Indirect Cost: ¥1,020,000); Fiscal Year 2010: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000); Fiscal Year 2009: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000); Fiscal Year 2008: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
• Keywords: 医療・福祉 / 医薬生物統計 / 臨床試験

Research Abstract

This research aimed at proposal of an appropriate design of clinical trials to establish most effective and safe treatment for patients suffering from various diseases. We propose the methods which take the quantitative balance between efficacy and safety into account. The methods need less number of patients than conventional methods. As a result, clinical trial with the proposed methods will be completed in shorter period.

Research Products

• [Journal Article] Statistical Tests Based on New Composite Hypotheses in Clinical Trials Reflecting the Relative Clinical Importance of Multiple Endpoints Quantitatively (2009)
  • Author(s): Nishikawa M., Tango T., Ohtaki M.
  • Journal Title: Biometrical Journal Vol.51 Pages: 749-762
  • Peer Reviewed
• [Journal Article] Statistical tests based on new composite hypotheses in clinical trials reflecting the relative clinical importance of multiple endpoints quantitatively (2009)
  • Author(s): Nishikawa M, Tango T, Ohtaki M.
  • Journal Title: Biometrical Journal 51 Pages: 749-762
  • Peer Reviewed
• [Journal Article] 生存時間解析における競合リスクモデル (2008)
  • Author(s): 西川正子
  • Journal Title: 計量生物学会 29巻 Pages: 141-170
  • NAID: 10025158022
  • Peer Reviewed
• [Journal Article] 生存時間解析における競合リスクモデル (2008)
  • Author(s): 西川正子
  • Journal Title: 計量生物学会 29 Pages: 141-170
  • NAID: 10025158022
  • Peer Reviewed
• [Presentation] One sided-tests based on efficacy-toxicity trade-off in randomized controlled trials (2010)
  • Author(s): Nishikawa M., Tango T., Ohtaki M., Hida E.
  • Organizer: XXVth International Biometric Conference
  • Place of Presentation: Florianopolis, Brasil
  • Year and Date: 2010-12-10
• [Presentation] One sided-tests based on efficacy-toxicity trade-off in randomized controlled trials. (2010)
  • Author(s): Nishikawa M, Tango T, Ohtaki M, Hida E.
  • Organizer: XXVth International Biometric Conference.
  • Place of Presentation: Florianopolis, Brasil.
  • Year and Date: 2010-12-10
• [Presentation] 臨床比較試験における2つのイベント発現までの時間の相対的な医学的重さを考慮した複合仮説と検定 (2010)
  • Author(s): 西川正子, 丹後俊郎, 大瀧慈, 飛田英祐
  • Organizer: 2009年度統計関連学会連合大会
  • Place of Presentation: 京田辺市
  • Year and Date: 2010-09-07
• [Presentation] 臨床比較試験における有効性と安全性のトレードオフを加味した仮説検定 (2010)
  • Author(s): 西川正子、丹後俊郎、大瀧慈、飛田英祐
  • Organizer: 2010年度統計関連学会連合大会
  • Place of Presentation: 新宿区
  • Year and Date: 2010-09-06
• [Presentation] 抗癌剤第II相臨床試験の多段階デザインにおける早期無効中止基準に関する検討 (2010)
  • Author(s): 中川智文、西川正子、丹後俊郎
  • Organizer: 2010年度統計関連学会連合大会
  • Place of Presentation: 新宿区
  • Year and Date: 2010-09-06
• [Presentation] 臨床比較試験における有効性と安全性のトレードオフを加味した仮説検定 (2010)
  • Author(s): 西川正子, 丹後俊郎, 大瀧慈, 飛田英祐
  • Organizer: 2010年度統計関連学会連合大会
  • Place of Presentation: 東京都新宿区
  • Year and Date: 2010-09-06
• [Presentation] 抗癌剤第II相臨床試験の多段階デザインにおける早期無効中止基準に関する検討 (2010)
  • Author(s): 中川智文, 西川正子, 丹後俊郎
  • Organizer: 2010年度統計関連学会連合大会
  • Place of Presentation: 東京都新宿区
  • Year and Date: 2010-09-06
• [Presentation] 部分的区間打ち切りデータにおける二標本検定法の比較と評価について (2010)
  • Author(s): 川口修、飛田英祐、西川正子、丹後俊郎
  • Organizer: 2010年度日本計量生物学会年会
  • Place of Presentation: 東京都立川市
  • Year and Date: 2010-05-21
• [Presentation] New Composite Hypotheses and Statistical Tests in Randomized Clinical Trial where two time to event data are primary Endpoints (2010)
  • Author(s): Nishikawa M., Tango T., Ohtaki M., Hida E.
  • Organizer: East Asia Regional Biometric Conference
  • Place of Presentation: Manipal, India
  • Year and Date: 2010-02-12
• [Presentation] Statistical tests based on new composite hypotheses for time to event data in clinical trials reflecting the relative clinical importance (2010)
  • Author(s): 西川正子, 丹後俊郎, 大瀧慈, 飛田英祐
  • Organizer: East Asia Regional Biometric Conference
  • Place of Presentation: Manipal, India
  • Year and Date: 2010-02-12
• [Presentation] 臨床比較試験における2つのイベント発現までの時間の相対的な医学的重さを考慮した複合仮説と検定 (2009)
  • Author(s): 西川正子、丹後俊郎、大瀧慈、飛田英祐
  • Organizer: 2009年度統計関連学会連合大会
  • Place of Presentation: 京田辺市
  • Year and Date: 2009-09-07
• [Presentation] Statistical tests based on new composite hypotheses for time to event data in clinical trials reflecting the relative clinical importance. (2008)
  • Author(s): Nishikawa M., Tango T., Ohtaki M.
  • Organizer: XXIVth International Biometric Conference
  • Place of Presentation: Dublin, Ireland
  • Year and Date: 2008-07-15
• [Presentation] Statistical tests based on new composite hypotheses for time to event data in clinical trials reflecting the relative clinical importance (2008)
  • Author(s): Nishikawa, et al.
  • Organizer: The XXIVth International Biometric Conference
  • Place of Presentation: Dublin, Ireland
  • Year and Date: 2008-07-15
• [Book] 医学統計学の事典(丹後俊郎,小西貞則,編集)(区間打ち切りデータの解析) (2010)
  • Author(s): 西川正子
  • Publisher: 朝倉書店
• [Book] 医学統計学の事典(丹後俊郎,小西貞則,編集)(競合リスクモデル) (2010)
  • Author(s): 西川正子
  • Publisher: 朝倉書店
• [Book] 医学統計学の事典(丹後俊郎,小西貞則,編集)(複数のエンドポイントの包括的検定) (2010)
  • Author(s): 西川正子
  • Publisher: 朝倉書店
• [Book] 医学統計学の事典(丹後俊郎,小西貞則,編集)(有害事象の解析) (2010)
  • Author(s): 西川正子
  • Publisher: 朝倉書店
• [Book] 複数のエンドボイントの包括的検定In : 医学統計学の事典(丹後俊郎, 小西貞則編集) (2010)
  • Author(s): 西川正子
  • Publisher: 朝倉書店
• [Book] 有害事象の解析In : 医学統計学の事典(丹後俊郎, 小西貞則編集) (2010)
  • Author(s): 西川正子
  • Publisher: 朝倉書店