1. CSMUH Clinical Trial Centers
Experiences on The
Implementation of Clinical Trials
James Cheng-Chung Wei, MD, Ph.D.
Chief, Division of Allergy, Immunology and Rheumatology
Director, Chinese Medicine Clinical Trial Center
Chung Shan Medical University Hospital
Taichung, Taiwan.

2. Outlines
1.
2.
3.
Global clinical trials trends
CSMUH experiences
Suggestions to sites, sponsors & health
authorities

3. Map of All Studies in
ClinicalTrials.gov

4. All Studies in ClinicalTrials.gov
Asia Pacific area
Taiwan 1537
2. Korea 1455
3. China 1372
4. Japan 1305
5. India 1115
6. Thailand 602
7. Singapore 588
8. Hong Kong 462
9. Philippines 339
10. Malaysia 279
1.

Australia 2373

New Zealand 553

6. How did sites/countries selected

7. Country Attractiveness Index for Clinical Trials

8. Source of subjects for interventional
clinical trials, Nov 15, 2013 Kmr Group

9. Taiwan Strength in Clinical Trials







Population size 2.3 million
Patients pooling, coverage of national
insurance
PI reputation
CRO/Site Team GCP quality
Study site cost
Regulatory framework efficiency
IRB review time and quality

10. Outlines
1.
2.
3.
Global clinical trials trends
CSMUH experiences
Suggestions to sites, sponsors & health
authorities

11. Chung Shan Medical University Hospital
•
•
•
•
•
One of 4 medical centers in mid-Taiwan
1500 beds, 4 districts
Certify by ISO27001, FERCAP
Inspected by TFDA, FDA, Japan PMDA
Contract template with Norvatis, GSK,
Sanofi
Chung Shan Medical
University Hospital
Chinese Medicine Clinical Trial Center

12. Chung Shan Medical University Hospital
GCRC (General Clinical Research Center)

SMO (site-management organization)
model granted by the DOH, Taiwan
SMO (site-management organization)
SMO (site-management organization)
GCRC (General Clinical Research Center)
GCRC (General Clinical Research Center)
CMCTC Chinese Medicine Clinical Trial Center
CMCTC Chinese Medicine Clinical Trial Center
Clinical affairs
Clinical affairs
Administrative
Administrative
1 CRA/HN
1 CRA/HN
2 assistants
2 assistants
9 CRC
9 CRC
Data management
Data management 3 MD
3 MD
1 Statistic PhD
1 Statistic PhD
1 Pharmacist
1 Pharmacist
2 Statistic MS
Statistic MS
2

13. CSMUH Chinese Medicine Clinical Trial Center
04

15. Clinical Trials in CSMUH

16. Clinical trials in CSMUH

17. Clinical trials in CSMUH

18. Dr. Wei Global Trials Experiences
About 60 trials in the past 5 years, 27 trials ongoing.
**World top one enroller in
-Norvatis RHAK study: IL-17 MoAb in ankylosing spondylitis.
-Pfizer: Etanercept in non-radiographic axial spondyloarthritis.
**Taiwan top one enroller in
-BMS IM101-174: Abatacept in rheumatoid arthritis
-UCB RA-0083: Anti-IL6 in rheumatoid arthritis
-MSD MK0663-108: Etoricoxib in ankylosing spondylitis
-Twi: IL-1 receptor antagonist in gouty arthritis
-TSH: TuNex (Etanercept biosimilar) in rheumatoid arthritis

19. FDA inspection
CSMUH, Oct 18-20, 2010.

20. ＳＬＥ
20

21. BLISS Phase 3 Geography
Austria
Belgium
Czech Republic
US
France
Puerto Rico
Germany
Canada
Israel
Mexico
Italy
Costa Rica
The Netherlands
Poland
Romania/Romania
Romania/Romania
Russia
Argentina
Brazil
Chile
Colombia
Australia
Hong Kong
Slovakia
India
Spain
Korea
Sweden
The Philippines
UK
Taiwan
Peru
1,693 patients from 223 centers in 31 countries
21
CONFIDENTIAL July 2009

22. Enrollment - BLISS-52
867 patients from 90 centers in 13 countries
22
CONFIDENTIAL July 2009

24. Dr Wei Academia Credits

Steering committee and paper authorship
•
•
•
•

Etanercept in axial spondyloarthritis
Tofacitinib in ankylosing spondylitis
ASAS classification criteria for Spondyloarthritis
Treating spondyloarthritis, including ankylosing
spondylitis and psoriatic arthritis, to target:
recommendations of an international task force.
International Advisory Board
•
•
•
Pfizer, Etanercept
Abbvie, Adalimumab
UCB, Certolizumab Pegol

25. My Investigator-Initiated Studies
1.
2.
3.
4.
5.
6.
Immunogenicity, adalimumab levels and clinical response in ankylosing
spondylitis patients during 24 weeks of follow-up. Annals Rheum Dis 2013
Tramadol/acetaminophen combination (Ultracet) as add-on therapy in the
treatment of patients with ankylosing spondylitis. Clin Rheumatol 2013
Efficacy and Safety of Herbal Medicine Yun-Cai Tea in the Treatment of
Hyperlipidemia: A Double-Blind Placebo-controlled Clinical Trial. Chinese
Journal of Integrative Medicine 2013
A randomized, double-blind, placebo-controlled study to evaluate the
efficacy and tolerability of Danshen (Salvia miltiorrhiza) as add-on antihypertensive therapy in Taiwanese patients with uncontrolled hypertension.
Phytotherapy Research 2012
Vitamin B6 supplementation improves pro-inflammatory responses in
patients with rheumatoid arthritis. Eur J Clin Nutr. 2010
Efficacy and immunomodulation of Sterols/Sterolins in patients with
allergic rhinitis: A randomized double blind placebo-controlled clinical trial.
Formosan Journal of Rheumatology 2009

26. Consortium for Globalization of
Chinese Medicine, CGCM

28. Outlines
1.
2.
3.
Global clinical trials trends
CSMUH experiences
Suggestions to sites, sponsors & health
authorities

29. Suggestions to Sites

IRB process
• CIRB/JIRB fast track

Contract process
• Sponsor-Site template, DOH template


Access to HIS, eg. Data mining, Alert
EMR
• tracking system and CRA/CRC authentication

More support to clinical trials
• Space, manpower, study fee usage

30. Suggestions to Sponsors


Bring more studies to Taiwan
More budget
• PI fee/ SC fee/ Lab tests
• Ask additional fee, eg. Feasibility survey fee,
Overhead fee, start-up fee, SAE reporting fee


Recruitment network and advertising
Support on PI-initiated studies

31. Suggestions to DOH








DOH/CDE process
IRB evaluation
Template of clinical trials contract
Researcher network or consortium
Bridging rules to China
TCM licenses need clinical trials
All doctors can prescribe TCM
Health foods also need clinical trials

32. Conclusions
1.
2.
3.
4.
5.
Taiwan has strengths in clinical trials
quality and patients pooling
Clinical trials business is arising
Need to improve IRB/Contract process
Bridging regulations to China and Asia
countries
TCM and health foods also need clinical
trials to prove efficacy and safety

33. Chung Shan Medical University Hospital
Clinical Trial Center
James Cheng-Chung Wei, M.D., Ph.D.
Taichung, Taiwan
wei3228@gmail.com, +886 975 128095
Chung Shan Medical University Hospital
Chinese Medicine Clinical Trial Center