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

2. ・ 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 Contents of Presentation

3. Definition of clinical trial Clinical Trials Final & indispensable Stage 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 14 Paragraph 7; Article 19-2, Paragraph 4 and Article 23) Pharmaceutical Affairs Law, Article 2-7

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

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

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

7. Problems of clinical trial in Japan (2) Three problems (1)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. The Large Scale clinical trial Network (1) Purpose Creating innovative environment of clinical trials in Japan Ensuring the availability better medicines to people

10. The Large Scale clinical trial Network (2) Function Securing the number of cases required for clinical trials promptly

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

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