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Statistical research on design of clinical trials where the exact time to event can not be obseved

Research Project

Project/Area Number 23500365
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Statistical science
Research InstitutionNational Institute of Public Health

Principal Investigator

NISHIKAWA Masako  国立保健医療科学院, 研究情報支援研究センター, 上席主任研究官 (50373395)

Co-Investigator(Renkei-kenkyūsha) TANGO Toshiro  昭和女子大学 (70124477)
Project Period (FY) 2011 – 2013
Project Status Completed (Fiscal Year 2013)
Budget Amount *help
¥5,070,000 (Direct Cost: ¥3,900,000、Indirect Cost: ¥1,170,000)
Fiscal Year 2013: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2012: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2011: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Keywords医薬生物 / ゲノム統計解析 / 医療 / 臨床試験 / 医療・福祉 / 医薬生物統計
Research Abstract

As common practice, if the exact time of occurrence is not known due to interval-censoring, a single point imputation (e.g. right-point imputation) for the censoring interval is most often done as though it was the exact time of event and the standard survival analysis are performed. On the other hand, there are several corresponding methods to interval-censored data. Zao's method is one of them. It was found that Zao's method does not maintain type I error probability in our preliminary research. We explored characteristics of single point imputations and Zao's method deeply, and reported the results at an international conference. We tried to improve Zao's method. While using R to evaluate an improved statistics, we found unstable performance of a package (IntCox). We consider some remedies for 'IntCox' and will report the results at an international conference.

Report

(4 results)
  • 2013 Annual Research Report   Final Research Report ( PDF )
  • 2012 Research-status Report
  • 2011 Research-status Report
  • Research Products

    (29 results)

All 2014 2013 2012 2011

All Journal Article (4 results) (of which Peer Reviewed: 2 results) Presentation (21 results) (of which Invited: 1 results) Book (4 results)

  • [Journal Article] Atorvastatin, Etidronate, or Both in Patients at High Risk for Atherosclerotic Aortic Plaques : a Randomized Controlled Trial2013

    • Author(s)
      Tetsuya Kawahara, Masako Nishikawa, Tetsuya Furusawa, Tetsuya Inazu, Gen Suzuki
    • Journal Title

      Circulation

      Volume: 127(23) Pages: 2327-35

    • Related Report
      2013 Final Research Report
  • [Journal Article] Effects of lifestyle education program for type 2 diabetes patients in clinics : a cluster randomized controlled trial2013

    • Author(s)
      Misa Adachi, Kazue Yamaoka, Mariko Watanabe, Masako Nishikawa, Itsuro Kobayashi, Eisuke Hida and Toshiro Tango
    • Journal Title

      BMC Public Health

      Volume: 13 Pages: 467-467

    • Related Report
      2013 Final Research Report
  • [Journal Article] Atorvastatin, Etidronate, or Both in Patients at High Risk for Atherosclerotic Aortic Plaques: a Randomized Controlled Trial.2013

    • Author(s)
      Tetsuya Kawahara, Masako Nishikawa, Tetsuya Furusawa, Tetsuya Inazu, Gen Suzuki.
    • Journal Title

      Circulation.

      Volume: 11;127(23) Pages: 2327-35

    • Related Report
      2013 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Effects of lifestyle education program for type 2 diabetes patients in clinics: a cluster randomized controlled trial.2013

    • Author(s)
      Misa Adachi, Kazue Yamaoka, Mariko Watanabe, Masako Nishikawa, Itsuro Kobayashi, Eisuke Hida and Toshiro Tango.
    • Journal Title

      BMC Public Health

      Volume: 13 Issue: 1 Pages: 467-467

    • DOI

      10.1186/1471-2458-13-467

    • Related Report
      2013 Annual Research Report
    • Peer Reviewed
  • [Presentation] Remedy for 'IntCox' in partly interval-censored Survival data.2014

    • Author(s)
      Nishikawa M., Mizukami H., Morikawa T., Yokoyama T.
    • Organizer
      35th Annual Conference of the International Society for Clinical Biostatistics
    • Place of Presentation
      Vienna, Austria
    • Related Report
      2013 Annual Research Report
  • [Presentation] 入院医療機関における処置と患者の状況の検討(1)-在院日数別看護必要度得点の推移-2013

    • Author(s)
      西川正子. 筒井孝子. 東野定律. 大夛賀政昭
    • Organizer
      第72回日本公衆衛生学会, 日本公衆衛生雑誌
    • Place of Presentation
      津市
    • Related Report
      2013 Final Research Report
  • [Presentation] 入院医療機関における処置と患者の状況の検討(2)-認知症有無別看護必要度得点の比較-2013

    • Author(s)
      筒井孝子. 東野定律. 大夛賀政昭. 西川正子
    • Organizer
      第72回日本公衆衛生学会, 日本公衆衛生雑誌
    • Place of Presentation
      津市
    • Related Report
      2013 Final Research Report
  • [Presentation] 入院医療機関における処置と患者の状況の検討(1)-在院日数別看護必要度得点の推移-.2013

    • Author(s)
      西川正子. 筒井孝子. 東野定律. 大夛賀政昭.
    • Organizer
      第72回日本公衆衛生学会
    • Place of Presentation
      津市
    • Related Report
      2013 Annual Research Report
  • [Presentation] 入院医療機関における処置と患者の状況の検討(2)-認知症有無別看護必要度得点の比較-.2013

    • Author(s)
      筒井孝子. 東野定律. 大夛賀政昭. 西川正子.
    • Organizer
      第72回日本公衆衛生学会
    • Place of Presentation
      津市
    • Related Report
      2013 Annual Research Report
  • [Presentation] クラスター無作為化比較試験による2 型糖尿病のための生活習慣改善プログラムの介入効果の評価2012

    • Author(s)
      安達美佐, 山岡和枝, 渡辺満利子, 小林 逸郎, 西川正子, 飛田英佑, 丹後俊郎
    • Organizer
      第22回日本疫学会
    • Related Report
      2013 Final Research Report
  • [Presentation] Comparison of Two-Sample Tests for Partly Interval-Censored Survival Data2012

    • Author(s)
      Kawaguchi, Hida, Nishikawa, Yamaoka, and Tango
    • Organizer
      XXVIth International Biometric Conference
    • Place of Presentation
      Kobe, Japan
    • Related Report
      2013 Final Research Report
  • [Presentation] Effects of Lifestyle Education Program for Type 22012

    • Author(s)
      Adachi, Yamaoka, Watanabe, Nishikawa, Hida, and Tango
    • Organizer
      XXVIth International Biometric Conference
    • Place of Presentation
      Kobe, Japan
    • Related Report
      2013 Final Research Report
  • [Presentation] On the Adjustment of the cause-Specific Log-Rank Test in Competing Risks Data2012

    • Author(s)
      Nishikawa, Taguchi, Akazawa, and Takahashi
    • Organizer
      XXVIth International Biometric Conference
    • Place of Presentation
      Kobe, Japan
    • Related Report
      2013 Final Research Report
  • [Presentation] Mixture Models for Epileptic Seizure Counts2012

    • Author(s)
      Uehara, Nishikawa, Takahashi, Hida, Yamaoka and Tango
    • Organizer
      XXVIth International Biometric Conference
    • Place of Presentation
      Kobe, Japan
    • Related Report
      2013 Final Research Report
  • [Presentation] Time to event dataを評価尺度とする臨床試験の競合リスクに関わる最近の話題2012

    • Author(s)
      西川正子, 田口和伸
    • Organizer
      第40回日本行動計量学会, 第40回日本行動計量学会特別セッション講演集別冊
    • Place of Presentation
      新潟市
    • Related Report
      2013 Final Research Report
  • [Presentation] Comparison of Two-Sample Tests for Partly Interval-Censored Survival Data.2012

    • Author(s)
      Kawaguchi, Hida, Nishikawa, Yamaoka, and Tango.
    • Organizer
      XXVIth International Biometric Conference. Kobe, Japan. 2012.8.
    • Place of Presentation
      Kobe, Japan.
    • Related Report
      2012 Research-status Report
  • [Presentation] Effects of Lifestyle Education Program for Type 2 Diabetes.2012

    • Author(s)
      Adachi, Yamaoka, Watanabe, Nishikawa, Hida, and Tango.
    • Organizer
      XXVIth International Biometric Conference. Kobe, Japan. 2012.8.
    • Place of Presentation
      Kobe, Japan.
    • Related Report
      2012 Research-status Report
  • [Presentation] On the Adjustment of the cause-Specific Log-Rank Test in Competing Risks Data.2012

    • Author(s)
      Nishikawa, Taguchi, Akazawa, and Takahashi.
    • Organizer
      XXVIth International Biometric Conference. Kobe, Japan. 2012.8.
    • Place of Presentation
      Kobe, Japan.
    • Related Report
      2012 Research-status Report
  • [Presentation] Mixture Models for Epileptic Seizure Counts.2012

    • Author(s)
      Uehara, Nishikawa, Takahashi, Hida, Yamaoka and Tango.
    • Organizer
      XXVIth International Biometric Conference. Kobe, Japan. 2012.8.
    • Place of Presentation
      Kobe, Japan.
    • Related Report
      2012 Research-status Report
  • [Presentation] Time to event dataを評価尺度とする臨床試験の競合リスクに関わる最近の話題.2012

    • Author(s)
      西川正子, 田口和伸.
    • Organizer
      第40回日本行動計量学会
    • Place of Presentation
      新潟市
    • Related Report
      2012 Research-status Report
    • Invited
  • [Presentation] クラスター無作為化比較試験による2型糖尿病のための生活習慣改善プログラムの介入効果の評価.2012

    • Author(s)
      安達美佐, 山岡和枝, 渡辺満利子, 小林 逸郎, 西川正子, 飛田英佑, 丹後俊郎.
    • Organizer
      第22回日本疫学会
    • Place of Presentation
      東京
    • Related Report
      2011 Research-status Report
  • [Presentation] Sensitivity analysis for a cluster randomized trial on effects of lifestyle education program for type 2 diabetes in clinics2011

    • Author(s)
      Kazue Yamaoka, Misa Adachi, Mariko Watanabe, Masako Nishikawa, and Toshiro Tango
    • Organizer
      32nd Annual conference of the International Society for Clinical Biostatistics
    • Place of Presentation
      Ottawa, Canada
    • Related Report
      2013 Final Research Report
  • [Presentation] 糖尿病のための個別生活習慣改善プログラムによる教育効果の評価2011

    • Author(s)
      安達美佐, 山岡和枝, 渡辺満利子, 西川正子, 飛田英佑, 丹後俊郎
    • Organizer
      第70回日本公衆衛生学会
    • Place of Presentation
      秋田市
    • Related Report
      2013 Final Research Report
  • [Presentation] Sensitivity analysis for a cluster randomized trial on effects of lifestyle education program for type 2 diabetes in clinics.2011

    • Author(s)
      Kazue Yamaoka, Misa Adachi, Mariko Watanabe, Masako Nishikawa, and Toshiro Tango.
    • Organizer
      32nd Annual conference of the International Society for Clinical Biostatistics
    • Place of Presentation
      Ottawa, Canada.
    • Related Report
      2011 Research-status Report
  • [Presentation] 糖尿病のための個別生活習慣改善プログラムによる教育効果の評価.2011

    • Author(s)
      安達美佐, 山岡和枝, 渡辺満利子, 西川正子, 飛田英佑, 丹後俊郎.
    • Organizer
      第70回日本公衆衛生学会
    • Place of Presentation
      秋田市
    • Related Report
      2011 Research-status Report
  • [Book] 臨床試験. In : 統計応用の百科事典(松原望, 美添泰人, 編集委員長)2011

    • Author(s)
      西川正子
    • Publisher
      東京 : 丸善出版
    • Related Report
      2013 Final Research Report
  • [Book] 臨床試験における無作為割付け. In : 統計応用の百科事典(松原望, 美添泰人, 編集委員長)2011

    • Author(s)
      西川正子
    • Publisher
      東京 : 丸善出版
    • Related Report
      2013 Final Research Report
  • [Book] 臨床試験.In: 統計応用の百科事典(松原望, 美添泰人,編集委員長).2011

    • Author(s)
      西川正子.
    • Publisher
      丸善出版
    • Related Report
      2011 Research-status Report
  • [Book] 臨床試験における無作為割付け.In: 統計応用の百科事典(松原望, 美添泰人,編集委員長).2011

    • Author(s)
      西川正子.
    • Publisher
      丸善出版
    • Related Report
      2011 Research-status Report

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Published: 2011-08-05   Modified: 2019-07-29  

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