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Construction of clinical trial management system used for multi-center trial

Research Project

Project/Area Number 17390149
Research Category

Grant-in-Aid for Scientific Research (B)

Allocation TypeSingle-year Grants
Section一般
Research Field Medical sociology
Research InstitutionNiigata University

Principal Investigator

TOYABE Shin-ichi  Niigata University, Medical and Dental Hospita, Associate Professor, 医歯学総合病院, 助教授 (20227648)

Co-Investigator(Kenkyū-buntansha) AKAZAWA Kouhei  Niigata University, Medical and Dental Hospital, Professor, 医歯学総合病院, 助教授 (10175771)
NAKATA Koh  Niigata University, Medical and Dental Hospital, Professor, 医歯学総合病院, 教授 (80207802)
Project Period (FY) 2005 – 2006
Project Status Completed (Fiscal Year 2006)
Budget Amount *help
¥13,900,000 (Direct Cost: ¥13,900,000)
Fiscal Year 2006: ¥6,000,000 (Direct Cost: ¥6,000,000)
Fiscal Year 2005: ¥7,900,000 (Direct Cost: ¥7,900,000)
KeywordsClinical trial / Multi-center trial / Internet / Hospital information system / Database / Geographic information system / GIS
Research Abstract

Number of clinical trials has not been increased after introduction of Good Clinical Practice (GCP) in Japan. Multi-center trial is expected to increase the number of clinical trials. However, there are several problems to conduct clinical trials in Japan. It is hard to know how many patients are expected to enter the clinical trial before the start of the clinical trial. First, we constructed a system to know how many patients who match the requirements of the clinical trials such as age, gender, diagnosis, disease stages, clinical examination or diagnostic imaging. Since there is a considerable diversity between the hospitals in the level of introduction of hospital information system (HIS), we tried to extract minimum information from HIS. The extracted information was stored in the server and can be accessed by Internet. The minimum system can be used in various hospitals with various levels of computerized medicine. Next, we constructed a system which enabled to extract in-depth clinical information in the University hospital, where highly sophisticated HIS was introduced. It would be expected to construct high performance system, if such high-function HIS was introduce to every hospitals. Next, we tried to construct a system to exchange information on patients between hospitals that entered multi-center trials. We made a system to send information on entry to a clinical trial and to serve the data on the patients. We plan to expand the system to deal with the data of follow-up referred to the patients. When multi-center trial starts, it is important which hospitals to enter the trials. To assist to the decisions, we studied situation of hospital-to-hospital coordination and medical service area of each hospital by using geographic information system (GIS). GIS clarified which hospitals is to be entered multi-center trial.

Report

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

    (7 results)

All 2006 2005 Other

All Journal Article (7 results)

  • [Journal Article] Referral from secondary care and to aftercare in a tertiary care university hospital in Japan.2006

    • Author(s)
      Toyabe S, et al.
    • Journal Title

      BMC Health Services Research 6

      Pages: 11-11

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] DPC関連情報と地理情報システム (GIS) を活用した逆紹介状況の解析2006

    • Author(s)
      烏谷部真一, 他
    • Journal Title

      医療情報学 26

      Pages: 41-46

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] Referral from secondary care and to aftercare in a tertiary care university hospital in Japan.2006

    • Author(s)
      Toyabe S, et al.
    • Journal Title

      BMC Health Sery Res 6

      Pages: 11-11

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] Analysis of Referrals from University Hospital by using information on DPC and GIS2006

    • Author(s)
      Toyabe S, et al.
    • Journal Title

      Japan Journal of Medical Informatics 26

      Pages: 41-46

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2006 Final Research Report Summary
  • [Journal Article] Actual and estimated costs of disposable materials used during surgical procedures2005

    • Author(s)
      Toyabe S
    • Journal Title

      Health Policy 73(1)

      Pages: 52-57

    • Related Report
      2005 Annual Research Report
  • [Journal Article] Development of a simulation program for hospital income under the prospective payment system2005

    • Author(s)
      Abe T
    • Journal Title

      Computer Methods and Programs in Biomedicine 80(3)

      Pages: 271-276

    • Related Report
      2005 Annual Research Report
  • [Journal Article] Impact of Sociocultural Factors on Hospital Length of Stay in Children with Nephrotic Syndrome in Japan

    • Author(s)
      Toyabe S
    • Journal Title

      Health Policy (In press)

    • Related Report
      2005 Annual Research Report

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

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