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Development and evaluation of a clinical trial simulation system by the second use of EMRs

Research Project

Project/Area Number 23790566
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Medical sociology
Research InstitutionKyoto University

Principal Investigator

SUMI Eriko  京都大学, 医学(系)研究科(研究院), 助教 (30452337)

Project Period (FY) 2011 – 2012
Project Status Completed (Fiscal Year 2013)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2012: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2011: ¥2,470,000 (Direct Cost: ¥1,900,000、Indirect Cost: ¥570,000)
Keywords医療情報学 / 臨床試験 / データ収集 / 二次利用 / 電子カルテ / シミュレーション
Research Abstract

I established the standard model of a data warehouse with a search system and data elements to retrieve from EMRs, which aims to predict the number of patients in a clinical trial. Then I established a method, i.e., how to translate the inclusion/exclusion criteria of a clinical trial into items in the items of the system, to search a patient in line with the inclusion/exclusion criteria of a clinical trial using EMRs search system. I evaluated the correlation between the estimated number of patients provided by the search system and the accrual achievement, and evaluated the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. Moreover, As the second use of EMRs, I carried out a pharmacoepidemiology study and pilot-study of a use of EMR templates as case report forms to collect the data.

Report

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

    (22 results)

All 2014 2013 2012 2011 Other

All Journal Article (8 results) (of which Peer Reviewed: 8 results) Presentation (10 results) (of which Invited: 2 results) Book (1 results) Remarks (3 results)

  • [Journal Article] The increase in prescriptions of bisphosphonates and the incidence proportion of osteonecrosis of the jaw after risk communication activities in Japan: a hospital-based cohort study.2014

    • Author(s)
      Sumi E, Yamazaki T, Tanaka S, Yamamoto K, Nakayama T, Bessho K, Yokode M
    • Journal Title

      Pharmacoepidemiol Drug Saf

      Volume: 23 Issue: 4 Pages: 398-405

    • DOI

      10.1002/pds.3562

    • NAID

      120005359202

    • Related Report
      2013 Annual Research Report 2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] The correlation between the number of eligible patients in routine clinical practice and the low recruitment level in clinical trials: a retrospective study using electronic medical records.2013

    • Author(s)
      Sumi E, Teramukai S, Yamamoto K, Satoh M, Yamanaka K, Yokode M
    • Journal Title

      Trials

      Volume: 14:426 Issue: 1 Pages: 426-426

    • DOI

      10.1186/1745-6215-14-426

    • NAID

      120005359200

    • Related Report
      2013 Annual Research Report 2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Risk factors and indices of osteomyelitis of the jaw in osteoporosis patients: results from a hospital-based cohort study in Japan.2013

    • Author(s)
      Yamazaki T, Yamori M, Tanaka S, Yamamoto K, Sumi E, Nishimoto-Sano M, Asai K, Takahashi K, Nakayama T, Bessho K.
    • Journal Title

      PLoS One

      Volume: 8(11) Issue: 11 Pages: e79376-e79376

    • DOI

      10.1371/journal.pone.0079376

    • Related Report
      2013 Annual Research Report 2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Risk of osteomyelitis of the jaw induced by oral bisphosphonates in patients taking medications for osteoporosis: a hospital-based cohort study in Japan.2012

    • Author(s)
      Yamazaki T, Yamori M, Yamamoto K, Saito K, Asai K, Sumi E, Goto K, Takahashi K, Nakayama T, Bessho K.
    • Journal Title

      Bone

      Volume: 51 Issue: 5 Pages: 882-887

    • DOI

      10.1016/j.bone.2012.08.115

    • Related Report
      2013 Final Research Report 2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] A pragmatic method for electronic medical record-based observational studies : developing an electronic medical records retrieval system for clinical research2012

    • Author(s)
      Yamamoto K, Sumi E, Yamazaki T, Asai K, Yamori M, Teramukai S, Bessho K, Yokode M, Fukushima M
    • Journal Title

      BMJ Open

      Volume: 2(6)

    • NAID

      120005122347

    • Related Report
      2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] An eClinical trial system for cancer that integrates with clinical pathways and electronic medical records2012

    • Author(s)
      Yamamoto K, Yamanaka K, Taura K, Fukushima M
    • Journal Title

      Clin Trials

      Volume: 9巻 Issue: 4 Pages: 408-417

    • DOI

      10.1177/1740774512445912

    • NAID

      120005323017

    • Related Report
      2013 Final Research Report 2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] A pragmatic method for electronic medical record-based observational studies: devel oping an electronic medical records retrieval system for clinical research.2012

    • Author(s)
      Yamamoto K, Sumi E, Yamazaki T, Asai K, Yamori M, Teramukai S, Bessho K, Yokode M, Fukushima M.
    • Journal Title

      BMJ Open

      Volume: 2 Issue: 6 Pages: e001622-e001622

    • DOI

      10.1136/bmjopen-2012-001622

    • NAID

      120005122347

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] An eClinical Trial System for Cancer that Integrates with Clinical Pathways and Electronic Medical Records2012

    • Author(s)
      Keiichi Yamamoto, Kenya Yamanaka, Etsuro Hatano, Eriko Sumi, Takamichi Ishii, Kojiro Taura, Kohta Iguchi, Satoshi Teramukai, Masayuki Yokode, Shinji Uemoto, Masanori Fukushima
    • Journal Title

      Clinical Trials

      Volume: in press

    • NAID

      120005323017

    • Related Report
      2011 Research-status Report
    • Peer Reviewed
  • [Presentation] 臨床研究・治験におけるICT活用の現状と今後2014

    • Author(s)
      角栄里子
    • Organizer
      大学病院情報マネジメント部門連絡会議
    • Year and Date
      2014-02-13
    • Related Report
      2013 Final Research Report
    • Invited
  • [Presentation] 臨床研究・治験におけるICT活用の現状と今後2014

    • Author(s)
      角 栄里子
    • Organizer
      大学病院情報マネジメント部門連絡会議
    • Place of Presentation
      ホテルクレメント徳島
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] 電子カルテを利用した臨床試験被験者リクルートメント予測指標の開発2012

    • Author(s)
      山本景一,角栄里子,手良向聡,横出正之
    • Organizer
      第16回医療情報学会春季学術大会
    • Year and Date
      2012-06-01
    • Related Report
      2013 Final Research Report
  • [Presentation] ビスフォスフォネート製剤関連顎骨壊死・顎骨骨髄炎の発生の経時的変化と、安全性情報提供の影響に関する調査2012

    • Author(s)
      角栄里子,山本景一,山崎亨,田中司朗,中山健夫,別所和久,横出正之
    • Organizer
      日本薬剤疫学会学術総会18回
    • Related Report
      2013 Final Research Report
  • [Presentation] 電子カルテ検索システムを利用した病院ベースの薬剤疫学研究の事例2012

    • Author(s)
      山本景一,角栄里子,山崎亨,家森正志,手良向聡,別所和久,横出正之,福島雅典
    • Organizer
      日本薬剤疫学会学術総会18回
    • Related Report
      2013 Final Research Report
  • [Presentation] ビスフォスフォネート製剤関連顎骨壊死・顎骨骨髄炎の発生の経時的変化と、安全性情報提供の影響に関する調査2012

    • Author(s)
      角 栄里子
    • Organizer
      第18回日本薬剤疫学会 学術総会
    • Place of Presentation
      東京慶應義塾大学芝共立キャンパス
    • Related Report
      2012 Research-status Report
  • [Presentation] 電子カルテ検索システムを利用した病院ベースの薬剤疫学研究の事例2012

    • Author(s)
      山本景一
    • Organizer
      第18回日本薬剤疫学会 学術総会
    • Place of Presentation
      東京慶應義塾大学芝共立キャンパス
    • Related Report
      2012 Research-status Report
  • [Presentation] 電子カルテを利用した 臨床試験被験者リクルートメント 予測指標の開発2012

    • Author(s)
      山本景一
    • Organizer
      第16回日本医療情報学会春季学術大会
    • Place of Presentation
      函館国際ホテル
    • Related Report
      2012 Research-status Report
  • [Presentation] Development of an Electronic Medical Record Retrieval System and transformation of eligibility criteria from free text to computable structure2011

    • Author(s)
      山本景一,角栄里子,手良向聡,横出正之
    • Organizer
      第32回日本臨床薬理学会年会
    • Year and Date
      2011-12-02
    • Related Report
      2013 Final Research Report
  • [Presentation] Development of an Electronic Medical Record Retrieval System and transformation of eligibility criteria from free text to computable structure2011

    • Author(s)
      Eriko Sumi, Keiichi Yamamoto, Satoshi Teramukai, Masayuki Yokode
    • Organizer
      第32回日本臨床薬理学会
    • Place of Presentation
      アクトシティ浜松(静岡県)
    • Related Report
      2011 Research-status Report
  • [Book] 電子カルテを利用した臨床試験被験者リクルートメント予測指標の開発, 医療情報学32巻6号

    • Author(s)
      山本景一,角栄里子,手良向聡,横出正之
    • Related Report
      2013 Final Research Report
  • [Remarks]

    • URL

      http://www.kuhp.kyoto-u.ac.jp/~rinsho/data/ekigaku_e1187.pdf,

    • Related Report
      2011 Research-status Report
  • [Remarks]

    • URL

      http://www.kuhp.kyoto-u.ac.jp/~rinsho/data/ekigaku_e1175.pdf

    • Related Report
      2011 Research-status Report
  • [Remarks]

    • URL

      http://www.kuhp.kyoto-u.ac.jp/~rinsho/data/ekigaku_e971.pdf

    • Related Report
      2011 Research-status Report

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

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