Presentation Transcript
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”
・Causes of “hollowing-out of clinical trial”
・”The Large Scale Clinical Trial Network”
- purpose, function, formation Contents of Presentation
Definition of clinical trial: 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
Current situation of clinical trial in Japan (1): Current situation of clinical trial in Japan (1) Dropping the No.
of clinical trials
conducted in Japan
Current situation of clinical trial in Japan (2): Current situation of clinical trial in Japan (2) Even domestic
companies conduct
their clinical trials
in foreign countries
Problems of clinical trial in Japan (1): 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
Problems of clinical trial in Japan (2): Problems of clinical trial in Japan (2) Three problems Time consuming
(2)Costly
(3) Poor quality WHY ? ?
Causes of hollowing-out of clinical trial : Causes of hollowing-out of clinical trial Lack of incentives
patients & researchers Poor infrastructures Need measures !
The Large Scale clinical trial Network (1) Purpose: The Large Scale clinical trial Network (1) Purpose Creating innovative
environment of clinical trials in Japan Ensuring the availability
better medicines to people
The Large Scale clinical trial Network (2) Function: The Large Scale clinical trial Network (2) Function Securing the number of cases
required for clinical trials promptly
The Large Scale clinical trial Network (3) Formation: 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
Slide12: “The Large Scale Clinical Trial Network (draft)” Japan Medical Association
(Secretariat)
○Jobs on conducting clinical trials
○Jobs on operating
OPSR
KIKO ③Consultation ④Answer PMDEC
Center ②Apply MHLW
Consultation, Advice Societies
Collecting requests ①Requests 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. Health Inst. Health Inst. Health Inst. 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