• Search Research Projects
  • Search Researchers
  • How to Use
  1. Back to previous page

A study on the introduction of statistical quality control method in clinical trials related industries

Research Project

Project/Area Number 22700288
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeSingle-year Grants
Research Field Statistical science
Research InstitutionHokkaido University

Principal Investigator

ITO Yoichi  北海道大学, 大学院・医学研究科, 准教授 (10334236)

Project Period (FY) 2010 – 2012
Project Status Completed (Fiscal Year 2012)
Budget Amount *help
¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000)
Fiscal Year 2012: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2011: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2010: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Keywords臨床試験 / データマネジメント / 統計的品質管理 / 教育プログラム開発
Research Abstract

In this study, in order to perform efficient clinical trials, we aimed educational program development of statistical quality control methods in the clinical trials related industries. In certain pharmaceutical companies, a developed educational program has done. In order to confirm the operational improving effect by statistical quality control techniques, a research on the data management process from the last patient out to the database locked was carried out. As a result, the process may be reduced to about 20 days from about 40 days.

Report

(4 results)
  • 2012 Annual Research Report   Final Research Report ( PDF )
  • 2011 Annual Research Report
  • 2010 Annual Research Report
  • Research Products

    (5 results)

All 2013 2011 Other

All Presentation (3 results) Remarks (2 results)

  • [Presentation] LeanSix Sigmaによるデータマネジメントプロセス改善の検討2013

    • Author(s)
      伊藤陽一,冨金原悟
    • Organizer
      日本臨床試験研究会第4回学術集会総会
    • Place of Presentation
      札幌
    • Related Report
      2012 Final Research Report
  • [Presentation] Lean Six Sigmaによるデータマネジメントプロセス改善の検討2013

    • Author(s)
      伊藤陽一、冨金原悟
    • Organizer
      日本臨床試験研究会第4回学術集会総会
    • Place of Presentation
      札幌
    • Related Report
      2012 Annual Research Report
  • [Presentation] 医学アカデミアでの生物統計家の貢献:現状と課題2011

    • Author(s)
      伊藤陽一
    • Organizer
      統計数理研究所リスク解析戦略研究センターシンポジウム
    • Place of Presentation
      東京都 品川インターシティ(招待講演)
    • Year and Date
      2011-02-17
    • Related Report
      2010 Annual Research Report
  • [Remarks]

    • URL

      http://biostat.med.hokudai.ac.jp/groups/d722f/wiki/6a7c9/index.html

    • Related Report
      2012 Final Research Report
  • [Remarks] 臨床試験関連業種における統計的品質管理手法の導入に関する研究

    • URL

      http://biostat.med.hokudai.ac.jp/groups/d722f/wiki/6a7c9/index.html

    • Related Report
      2012 Annual Research Report

URL: 

Published: 2010-08-23   Modified: 2019-07-29  

Information User Guide FAQ News Terms of Use Attribution of KAKENHI

Powered by NII kakenhi