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The Large Scale Clinical Trial Network

The Large Scale Clinical Trial Network. Mitsue Y. Hirota Ministry of Health, Labor and Welfare Research and Development Division. Contents of Presentation. ・ Current situation of clinical trial in Japan ・ Problems of clinical trial in Japan - “Hollowing-out of Clinical Trial”

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The Large Scale Clinical Trial Network

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  1. The Large Scale Clinical Trial Network Mitsue Y. Hirota Ministry of Health, Labor and Welfare Research and Development Division

  2. Contents of Presentation ・Current situation of clinical trial in Japan ・Problems of clinical trial in Japan - “Hollowing-out of Clinical Trial” ・Causes of “hollowing-out of clinical trial” ・”The Large Scale Clinical Trial Network” - purpose, function, formation

  3. Definition of clinical trial The term “clinical trial” in this Law refers to clinical trials performed for the purpose of collection of data related to the results of the clinical trial for inclusion among the data submitted pursuant to the provisions of Article 14, Paragraph 3(including application mutatis mutandis Article 14Paragraph 7; Article 19-2, Paragraph 4 and Article 23) Pharmaceutical Affairs Law, Article 2-7 Final & indispensable Stage Clinical Trials

  4. Currentsituation of clinical trial in Japan (1) Dropping the No. of clinical trials conducted in Japan

  5. Currentsituation of clinical trial in Japan (2) Even domestic companies conduct their clinical trials in foreign countries

  6. Problems of clinical trial in Japan (1) Even the domestic companies conduct their clinical trials in foreign countries Dropping the number of clinical trials conducted in Japan “Hollowing-out of Clinical Trial”

  7. Problems of clinical trial in Japan (2) Three problems • Time consuming • (2)Costly • (3) Poor quality WHY ? ?

  8. Causes of hollowing-out of clinical trial Lack of incentives patients & researchers Poor infrastructures Need measures !

  9. TheLarge Scale clinical trialNetwork (1) Purpose Creating innovative environment of clinical trials in Japan Ensuring the availability better medicines to people

  10. TheLarge Scale clinical trialNetwork (2) Function Securing the number of cases required for clinical trials promptly

  11. TheLarge Scale clinical trialNetwork (3) Formation Networking a number of medical institutions Ex. National Center, Designated function hospitals Establish secretariat as a center of networks Japan Medical Association

  12. “The Large Scale Clinical Trial Network (draft)” Japan Medical Association (Secretariat) ○Jobs on conducting clinical trials 　○Jobs on operating Societies Collecting requests Cooperation Pharmaceutical Companies ①Requests Coordination of societies’ requests Making Priority List etc. Hearing PMDEC Center ②Apply MHLW Consultation, Advice Data management, Making contracts Planning, Budgets matters Subsidy Unify 2004 ③Consultation OPSR KIKO ④Answer Establish 10 NWs within 3 yr NW for Cancer Study ・Technical support ・Central IRB, etc. NW for Child Disease study ・（＊）　 NW for Cardiovascular ・（＊） NW for AA ・（＊） NW for BB ・（＊） Health Inst. Health Inst. Health Inst. Health Inst. Health Inst. National Centers, Designated function hospitals, etc. ・（＊）　Same as NW for Cancer study

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