Welcome to
Asan
Medical Center
I. Research Infrastructure & Expertise
II. Clinical Trial Performances
III. Quality Clinical Trials
Research Infrastructure
and
Expertise
Major Statistics (2014)
11,380
2,714
1,671
39
80
9
3
Outpatients (daily)
Beds
Doctors
Research Beds for Phase 1 Studies
Dedicated Full-Time Staff at AMC CTC
IRB Regular Reviews per Month
Weeks, IRB Submission to Approval
Global Center of Excellence
in Clinical Trials
$ 9 mil funding for 5 years
Proof of Concept Trials
International Credit
AAHRPP
Full Accreditation, 2013
FERCAP Accreditation
2006: 1st in Korea
※ FERCAP: The Forum for Ethical Review Committees
in Asia and the Western Pacific Region
Clinical Trial Operation Timeline
Study Start-up
Study
Feasibility
IRB
Review
IN PARALLEL
Budgeting
Negotiation
Study Close-out
Study Conduction
I R B m ee t i n g: 9 /m o nt h
Mon: Regular Review
Fri: Ex pedited Rev ie w
Contract
Initiation
Meeting
Screening
FPFV
LPLV
Study Document & CRF Management
Adverse Event Management
IP Management
Budget Management
Internal Audit
CRF & Source
Document
Verification
Data Entry
& Validation
Laboratory
Analysis
* the median time from CTA proposal to conclusion: 29 days, 2013 SoCRA Annual Conference
PK/PD
Analysis
IRB Final
Report
Trial Activation Initiative
 Therapeutic Innovation & Regulatory Science, DIA
Trial Activation Initiative
 Trial Activation Initiative (Jul. 2012)
- Checklist for CTA review, Parallel IRB & CTA Review
Sequential process
Parallel process
IRB submission
Contract Request
- Budget review
- Negotiation
Contract Request
- Budget review
- Negotiation
IRB submission
IRB approval
IRB approval
CTA conclusion
CTA conclusion
117 days
61 days
e-IRB System
Management
Efficiency
Time
Cost
Clinical Research Data Warehouse
4 Million patients
De-identified
update every 3 Days
ABLE: Cohort Discovery
ABLE: De-identified Chart Review
Clinical Trial Management System
Dash.board
Study status

사용자 별 출력 화면 설정 기
능
 사용자 별 관심 연구 설정 기
능
 모니터링 관리, 자원자 관리
등 실시간알람 기능

Enrollment status
프로토콜 계획 대비 실제 등
록된 시험 대상자 수와 등록
률 그래프 조회
 시험대상자 탈락 현황 파악
(탈락율, 탈락사유 등)

Phase/질병/과제 진행현황 별
연구과제 리스트/건수/차트 조회
사용자 별로 혹은 CTMS에 등록
된 전체 연구 조회 가능
 하나 혹은여러개의차트로표시가
능

Report Generation
시행일자, 카테고리별 결과,
비고 등을 등록 및 조회
 연구과제, 시험 대상자, 연구
비, 연구자원, ARO에 등록된
정보에 대한 월별/분기별/연도
별 통계조회 및 자료 추출 지
원

Clinical Trial Center
 Outpatient Clinics (5)
 Consultation Room (5)
 Examination Room (6)
Clinical Trial Center
 Clinical Pharmacology Lab
 Clinical Pharmacy
 Storage (Deep freezers)
Clinical Trial Center
 Data Archiving Room (1)
 Constant Temperature
Chamber (1)
 Monitoring space : 9 Rooms, 21 Seats
(+3 rooms, 6 seats)
Phase I Unit for Healthy Volunteers
 24 exclusive beds
 Healthy Volunteers
 Central Monitoring System
 Convenient Facilities
Oncology Phase I Unit
 15 beds
 Phase I, II, PK study, Biomarker study
 Real-time central monitoring system
 Subject screening and physical examination room
Emergency & Intensive Care
Cancer
Emergency
Room
• CER located next to
phase I unit
Cardiac Care
Unit
• For possible severe
adverse events of
volunteers
Cardiologists
Support
• 24/7 available
• Share on-duty schedule
of Cardiologists
Resources for Translational Research
BioResource Center
• Primary cell culture
• Xenograft lines
• Pathology archives (Paraffin embedded cell/tissue blocks)
Core Labs
• Genomics, HTS (high throughput screening), Confocal
Microscopy, Flowcytometry, Metabolomics, Comparative
Pathology, Magenetic Resonance, PET, Optical Imaging
22
Clinical Trial Performances
Clinical Trials in AMC
Number of Trials Initiated Each Year
(based on the numbers of AMC IRB Approval)
Phase I
Phase II
Phase III
Phase IV
250
35
30
108
109
200
23
150
16
22
92
100
70
80
64
50
39
13
32
19
50
49
21
36
49
0
2010
2011
2012
2013
2014
Clinical Trials in AMC
Multicenter Studies (2013~2014)
Single
Center
18%
Multinational
Multicenter
54%
Local
Multicenter
28%
Therapeutic Area
(No.)
SIT: Sponsor Initiated Trial
IIT: Investigator Initiated Trial
200
180
160
140
120
100
80
60
40
Cardiology
Pulmonology Anesthesiology
2010
2011
2012
2013
2014
2010
2011
2012
2013
2014
Radiology
2010
2011
2012
2013
2014
Gastroenterology
2010
2011
2012
2013
2014
2010
2011
2012
2013
2014
Oncology
2010
2011
2012
2013
2014
0
2010
2011
2012
2013
2014
20
Urology
Number of Trials Initiated Each Year : Ph 1~4, PMS, others
Based on Numbers of AMC IRB Approval
Phase I Trials
49
50
7
45
36
40
3
35
30
25
20
15
28
21
16
Others
Cancer
Healthy Volunteer
3
7
17
10
11
14
5
0
2012
2013
2014
※ others: asthma, alzheimer, fabry, renal failure, hepatitis, genetic disorder, Crohn’s disease
First in Human
2011
2012
2013
2014
Cancer
1
0
1
4
Healthy Volunteer
2
3
3
1
Total
3
3
4
5
Thank you!
Asan Medical Center
Clinical Trial Center
http://ctc.amc.seoul.kr