Transcript Recent Developments in Clinical Trials in Korea

Key West, Fl., May 2009
B.I. Choe, M.B.A., LL.M., Ph.D.
Associate Professor of Bioethics
Nicholas Cardinal Cheong Graduate School for Life
Catholic Institute of Bioethics
The Catholic University of Korea
[email protected]
Recent Developments in Clinical Trials in Korea –
B.I.C.
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12 Regional CTCs in Korea
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Two IRBs in Korea
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Agent oriented, not Subject oriented
 IRB for Drug & Medical Device trials
 IRB for Genetic research
No governing laws or directives for
research involving human subjects
 Only government certified institutions
can and must operate IRB
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Regional Clinical Trial H/R
Development Centers
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Course development program for
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Investigator
Clinical Pharmacologist
Clinical Research Coordinator
Monitor
PK/PD professionals
Statistician / Data managers
Clinical trial pharmacist
Development of integrated online education program
for;
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HRPP
RCR
IRB
IACUC
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Recent Developments in Clinical Trials in Korea –
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Animal Protection Law
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Enacted Jan 2008
All institution using animals must be
registered
All institution must be reviewed by IACUC
All institution must conduct 8 hours course
on animal welfare for both Investigators
and Members of IACUC
Mandatory annual report
Lab Animal Law : K-FDA, enacted in 2009
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KAIRB
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Korea Association of IRBs
 An independent foundation of Korean IRBs
 Members : 49 institutions (IRBs)
 Funded by Ministry of Health, Welfare and
Family Affairs
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Development of Educational Programs
 Investigators : off-line course
 IRB reviewers : off-line course
 CITI-Korea : on-line course
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CITI-Korea and the Authorities
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RCR :
 Ministry of Education
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Human Subject Protection :
 Ministry of Health
 K-FDA
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Animal Research & IACUC :
 Ministry of Food, Agriculture, Forestry and
Fisheries.
 K-APHIS
 K-FDA
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Must Show the proof !
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Authorities are demanding
 the proof of education for
 investigators,
 members of review boards
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But, educational resources are
LIMITED !
 Everybody is expert
 No consolidated programs
 No assessment tools
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B.I. Choe, M.B.A., LL.M., Ph.D.
Director, CITI-Korea
The Catholic University of Korea
[email protected]
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B.I.C.
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