REACTA Forum 2014
참가후기
2014.11.21
세브란스병원
연구원 최청암
Outline
• REACTA Forum 2014
• Collaboration in industry
(NonTransCelerate)
• 제약회사 (Daiichi Sankyo)
• 임상시험 센터 (삼성서울병원 CTC)
• CRO (INC Research Korea)
REACTA (REgional Asian Clinical
Trial Association)
• CTC (주로 Asia 지역)의 모임
– Korea, Japan, Taiwan, HK, US, and Malaysia
• REACTA Forum 2014 부산 동아대에서 개최 2014.11.6-7
• Guiding purpose
– 상호 협력
– 교육
– Regulatory harmonization
1. Yoon-Duk Han, TransCelerate
OPTIMIZING THE CLINICAL TRIAL
PROCESS THROUGH
COLLABORATION
TransCelerate
• A non-profit organization focused on
advancing innovation in
– R&D
– Improving patient safety
– Delivering more high quality medicines
• Discusses issues facing the industry and
solution for addressing common challenges
• Support of the original 10 founding
biopharmaceutical company members
Source: TransCelerate, 2014 ARCS Scientific Congress
Source: TransCelerate, 2014 ARCS Scientific Congress
Source: TransCelerate, 2014 ARCS Scientific Congress
Source: TransCelerate, 2014 ARCS Scientific Congress
Source: TransCelerate, 2014 ARCS Scientific Congress
Source: TransCelerate, 2014 ARCS Scientific Congress
2. Koichi Miyazaki, Daichi Sankyo Co., Ltd
EFFICIENT MULTINATIONAL
CLINICAL TRIALS FOR PATIENTS
IN ASIA
Increasing trend of clinical trial
activity in Asia
Source: REACTA Forum 2014
The number of studies per 100 M
people
Sufficient capacity available in Asia for increased demend
Source: REACTA Forum 2014
Protocol deviation
(deviation/patient)
Source: REACTA Forum 2014
Proposed investigator grant for
completed case
Clinical trial in Asia is cost effective
Source: REACTA Forum 2014
Enrollment speed
(enrollment/sites)
Source: REACTA Forum 2014
Clinical trial by phase
Source: REACTA Forum 2014
Contribution from each region
• … small region
should contribute at
least 21.3% of the
patients…
• …guarantee
reasonable power of
… at least 20%
Asian authorities may request more data from Asia
Source: REACTA Forum 2014
Development strategy (past)
Source: REACTA Forum 2014
Development strategy
Source: REACTA Forum 2014
Clinical study in Asia
• Quality, cost and speed of Asia study are
competitive
• Asia should be involved from early stage
trial to consider ethnic differences
• Ideally, each region should contribute at
lease 20% of the patients to ensure the
consistency across regions
Source: REACTA Forum 2014
3. YoungSuk Park, SAMSUNG Medical Center CTC
SAMSUNG MEDICAL CENTER
CLINICAL TRIAL CENTER
SMC CTC Introduction
• 1995 1상 임상시험 실시기 • 2008 보건복지부 지역임상
관 지정
시험센터 및 3개부문 지정
• 2001 美보건아시아 최초로 • 2010 미래의학센터 설립
실시기관 및 IRB등록
• 2006 AAHRPP 전면인증
• 2007 Pfizer CORE
Research Site 지정
• 2012 BMS Oncology
Center of Excellence
Sanofi Premier Site 지정
• 2013 보건복지부 연구중심
병원 지정
Source: 삼성서울병원 임상시험센터 website
SMC CTC Introduction
1400
1200
1000
800
600
303
SIT
238
400
200
310
261
299
585
895
729
781
809
2010
2011
2012
2013
25
75
113
56
20
76
112
56
30
71
119
50
0
2009
Phase
Phase
Phase
Phase
Source: REACTA Forum 2014
1
2
3
4
IIT
Phase 1 Unit Team at CTC
□ Technology for early phase trials
□ Member
Researcher
Number
Pharmacologist
6
Pharmacist
2
Operation
1
CRC
Oncology 6
•
–
–
–
–
2
PK
6
Source: REACTA Forum 2014
Single ascending dose
Multiple ascending dose
Drug-Drug Interaction
BA/BE
•
Proof of Concept Study with New
Biomarkers
•
Through QT/QTc Study
•
Multi Omics
(Genomics/Proteomics/Metabolomics)
•
PK/PD M&S
•
New Statistical Tools for Innovative
Design
Healthy Volunteer 6
Nurse
Phase 1 Study
Personalized Tx Clinical at ICMI
Source: REACTA Forum 2014
SMC & Industry Collaboration
Cases
Source: REACTA Forum 2014
Translational CRO Functions
Source: REACTA Forum 2014
3. Hailey Chae, INC Research Korea
SITE SELECTION
Site Selection Process
•
•
•
•
Potential Investigators
Evaluate Criteria
Feasibility Study
Pre-study Visit
Source: REACTA Forum 2014
Identifying Potential Investigators
•
•
•
•
•
•
Literature Review
Medical Society Directories
Investigator Database
Reference from Investigator
Professional Colleagues
Regulatory Lists
Source: REACTA Forum 2014
Site Evaluation
• Experience with similar trials
• Interest Level (Prompt response for
feasibility & any queries)
• Patient pool
• Competing trials
• Resources (study coordinator/Sub-I/Rater)
• EC (SOP/approval timeline/contract process)
Source: REACTA Forum 2014
Site Evaluation
• Staff
– Study coordinator/Sub-I/Rater
– General interest & attitude
– Training
• Facility
– Storage for study supplies
– Archiving practices: study documents
– Device calibration: Freezer/Blood pressure
Source: REACTA Forum 2014
Certification
Competition
Compliance
Contract
Cost
Expertise
Experience
Equipment
Ethics committee
Local lab
Logistics
Language
Source: REACTA Forum 2014
Time
Training
Criteria
Subject
Staff
Space & storage
Selection of site is
both the Art and
Science of
Investigating
Investigator
Source: REACTA Forum 2014
Factors influencing clinical trial
site selection in Europe
• Applications to run clinical trials in Europe fell 25% between 2007
and 2011
• 19 factors explored: across investigator-driven, hospital-driven and
environment-driven criteria, and costs. It also surveyed
perceptions of the European trial environment
• Investigator-dependent, environment-dependent and hospitaldependent factors were rated highly important, costs being less
important
• Within environment-driven criteria, pool of eligible patients, speed
of approvals and presence of disease-management networks were
significantly more important than costs or government financial
incentives
Source: REACTA Forum 2014
Investigator-driven criteria in the
selection of phase II-III trial sites
Criteria
Mean
Investigator recruitment/retention track record 27.3
Investigator experience in previous trials
22.7
Investigator interest
22.4
Investigator concurrent workload
17.2
Investigator publication track record
10.4
Source: REACTA Forum 2014
Environment-driven criteria in the
selection of phase II-III trial sites
Criteria
Mean
Size of marketing/eligible patients in a region
23.8
Speed of MoH/Ethics committees approval
23.4
Disease management system/networks
18.9
Cost of running trial
15.2
Presence of country on ‘core country list’
11.8
Source: REACTA Forum 2014
Hospital-driven criteria in the
selection of phase II-III trial sites
Criteria
Mean
Site personnel experience and training
22.0
Previous experience with site
20.0
Facilities/equipment required by trial
19.7
Hospital approval/contracting system
17.4
Site personnel language proficiency
10.8
Source: REACTA Forum 2014
Source: REACTA Forum 2014
Institutional Considerations to
procure more projects
• Expand experience and qualified
investigator pool by active involvement of
sub-investigator group
• Establish and maintain qualified and welltrained study coordinator resource via
clinical trial center
• Update regular trial experience and patient
pool (Web-based/Newsletter)
• Streamline and control feasibility process
• Obtain regular feedback from industry
Source: REACTA Forum 2014
끝! 감사합니다.