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Construction of Clinical Trail Designs Database and Development of Security System for Personal Information Protection

Research Project

Project/Area Number 17606001
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field 臨床疫学
Research InstitutionThe University of Tokyo

Principal Investigator

HAYASHI Doubun  The University of Tokyo, Faculty of Medicine, Visiting Associate Professor, 医学部附属病院, 客員助教授 (80313104)

Co-Investigator(Kenkyū-buntansha) NAGAI Ryozo  The University of Tokyo, Faculty of Medicine, Professor, 医学部附属病院, 教授 (60207975)
KOHRO Takahide  The University of Tokyo, Faculty of Medicine, Visiting Assistant Professor, 医学部附属病院, 客員教員 (40401046)
OKADA Yoshihiro  The University of Tokyo, Faculty of Medicine, Visiting Assistant Professor, 医学部附属病院, 客員教員 (60323416)
Project Period (FY) 2005 – 2006
Project Status Completed (Fiscal Year 2006)
Budget Amount *help
¥3,600,000 (Direct Cost: ¥3,600,000)
Fiscal Year 2006: ¥1,000,000 (Direct Cost: ¥1,000,000)
Fiscal Year 2005: ¥2,600,000 (Direct Cost: ¥2,600,000)
Keywordsdatabase / clinical trials / study design / internet security / fingerprint authentication / lifestyle-related diseases / 個人情報セキュリティ / 大規模臨床試験 / セキュリティ / データベース管理
Research Abstract

Clinical trials require large numbers of participants followed over long periods of time, as well as a large amount of money and labor, especially in lifestyle-related diseases or other cardiovascular diseases.
The results of many studies, particularly those with negative findings are not published. This tendency is particularly true of those sponsored by pharmaceutical companies. Consequently, the findings are not available to the medical community or the general public, even if the data is useful. This situation has recently led to compulsory clinical trials registration in overseas countries. In Japan, several web sites for registration of clinical studies begin to emerge as well. On these web sites, information about clinical studies is supposed to be fairly provided, regardless of the negative or positive findings.
Considering the above situation, we conducted the following in this research project.
1)We have developed a web-accessible database for registration of clinical trial designs, which enables basic information about clinical trials to be provided fairly to healthcare professionals and the public.
2)We have set up a web site that introduces about 250 published clinical trials included in the Summary of Clinical Studies in Cardiovascular Diseases edited by Ryozo Nagai. Text mining capabilities have been added to the system with keyword searches.
3)In addition to authentication system using user IDs and passwords, we have studied about the adoption of fingerprint authentication techniques for registration and log management in the both web site to strengthen security of information system. We have also investigated the possibility of introduction of the techniques in actual clinical trials.
It is believed that fingerprint authentication systems are necessary in conducting clinical trials in the future in terms of both security and user-friendliness.

Report

(3 results)
  • 2006 Annual Research Report   Final Research Report Summary
  • 2005 Annual Research Report
  • Research Products

    (8 results)

All 2006 2005

All Journal Article (4 results) Book (4 results)

  • [Journal Article] SUMMARY OF CLINICAL STUDIES IN CARDIOVASCULAR DISEASES2006

    • Author(s)
      Ryozo N, Tsutomu Y, Doubun H, Takahide K, Yoshihiro O.
    • Journal Title

      OCC JAPAN K.K. 141

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] 高質の臨床研究のための新しいシステムの紹介2005

    • Author(s)
      林 同文
    • Journal Title

      MEDICAMENT NEWS 第1836号

      Pages: 8-9

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2006 Final Research Report Summary 2005 Annual Research Report
  • [Journal Article] Introduction of a New System for Conducting High-quality Clinical Studies.2005

    • Author(s)
      Doubun H.
    • Journal Title

      MEDICAMENT NEWS vol.1836

      Pages: 8-9

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] SUMMARY OF CLINICAL STUDIES IN CARDIOVASCULAR DISEASES 20052005

    • Author(s)
      Ryozo N, Tsutomu Y, Doubun H, Takahide K
    • Journal Title

      ATRICS K.K. 156

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Book] 循環器大規模臨床研究要約集 2006年度版SUMMARY OF CLINICAL STUDIES IN CARDIOVASCULAR DISEASES2006

    • Author(s)
      永井良三, 山崎力, 林同文, 興梠貴英, 岡田吉弘
    • Total Pages
      141
    • Publisher
      株式会社アトリクス
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Book] 循環器大規模臨床研究要約集2006年度版2006

    • Author(s)
      永井良三, 山崎力, 林同文, 興梠貴英, 岡田吉弘
    • Total Pages
      141
    • Publisher
      株式会社アトリクス
    • Related Report
      2006 Annual Research Report
  • [Book] 循環器大規模臨床試験要約集 2005年度版SUMMARY OF CLINICAL STUDIES IN CARDIOVASCULAR DISEASES2005

    • Author(s)
      永井良三, 山崎力, 林同文, 興梠貴英
    • Total Pages
      156
    • Publisher
      オーシーシー・ジャパン株式会社
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Book] 循環器大規模臨床試験要約集 SUMMARY OF CLINICAL STUDIES IN CARDIOVASCULAR DISEASES2005

    • Author(s)
      永井良三, 山崎力, 林同文, 興梠貴英
    • Total Pages
      156
    • Publisher
      オーシーシー・ジャパン株式会社
    • Related Report
      2005 Annual Research Report

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Published: 2005-04-01   Modified: 2016-04-21  

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