CSMUH Clinical Trial CentersCSMUH Clinical Trial CentersExperiences on The Experiences on The
Implementation of Clinical TrialsImplementation of Clinical Trials
James Cheng-Chung Wei, MD, Ph.D.James Cheng-Chung Wei, MD, Ph.D.
Chief, Division of Allergy, Immunology and Rheumatology Chief, Division of Allergy, Immunology and Rheumatology Director, Chinese Medicine Clinical Trial Center Director, Chinese Medicine Clinical Trial Center
Chung Shan Medical University Hospital Chung Shan Medical University Hospital
Taichung, Taiwan. Taichung, Taiwan.
OutlinesOutlines
1.1. Global clinical trials trendsGlobal clinical trials trends
2.2. CSMUH experiencesCSMUH experiences
3.3. Suggestions to sites, sponsors & health Suggestions to sites, sponsors & health authoritiesauthorities
Map of All Studies in Map of All Studies in ClinicalTrials.govClinicalTrials.gov
All Studies in ClinicalTrials.govAll Studies in ClinicalTrials.govAsia Pacific areaAsia Pacific area
1.1. Taiwan 1537Taiwan 15372.2. Korea 1455Korea 1455
3.3. China 1372 China 1372 4.4. Japan 1305 Japan 1305
5.5. India 1115 India 1115 6.6. Thailand 602 Thailand 602
7.7. Singapore 588Singapore 5888.8. Hong Kong 462Hong Kong 4629.9. Philippines 339Philippines 339
10.10. Malaysia 279Malaysia 279
Australia 2373 Australia 2373
New Zealand 553New Zealand 553
How did sites/countries selectedHow did sites/countries selected
Country Attractiveness Index for Clinical TrialsCountry Attractiveness Index for Clinical Trials
Source of subjects for interventional Source of subjects for interventional clinical trialsclinical trials, Nov 15, 2013 , Nov 15, 2013 Kmr GroupKmr Group
Taiwan Strength in Clinical TrialsTaiwan Strength in Clinical Trials
Population size 2.3 million Population size 2.3 million Patients pooling, coverage of national Patients pooling, coverage of national
insuranceinsurance PI reputationPI reputation CRO/Site Team GCP quality CRO/Site Team GCP quality Study site cost Study site cost Regulatory framework efficiencyRegulatory framework efficiency IRB review time and qualityIRB review time and quality
OutlinesOutlines
1.1. Global clinical trials trendsGlobal clinical trials trends
2.2. CSMUH experiencesCSMUH experiences
3.3. Suggestions to sites, sponsors & health Suggestions to sites, sponsors & health authoritiesauthorities
Chung Shan Medical Chung Shan Medical University HospitalUniversity Hospital
Chinese Medicine Clinical Trial Center
Chung Shan Medical University HospitalChung Shan Medical University Hospital
• One of 4 medical centers in mid-TaiwanOne of 4 medical centers in mid-Taiwan• 1500 beds, 4 districts1500 beds, 4 districts• Certify by Certify by ISO27001, FERCAPISO27001, FERCAP• Inspected by TFDA, FDA, Japan PMDAInspected by TFDA, FDA, Japan PMDA• Contract template with Contract template with Norvatis, GSK, Norvatis, GSK,
SanofiSanofi
Chung Shan Medical University HospitalChung Shan Medical University Hospital GCRC (General Clinical Research Center)GCRC (General Clinical Research Center)
SMO (site-management organization) SMO (site-management organization) model granted by the DOH, Taiwanmodel 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 CenterCMCTC Chinese Medicine Clinical Trial Center
SMO (site-management organization)SMO (site-management organization)
GCRC (General Clinical Research Center)GCRC (General Clinical Research Center) CMCTC Chinese Medicine Clinical Trial CenterCMCTC Chinese Medicine Clinical Trial Center
AdministrativeAdministrative 2 assistants2 assistantsAdministrativeAdministrative 2 assistants2 assistants
Clinical affairsClinical affairs 1 CRA/HN1 CRA/HN 9 CRC9 CRC
Clinical affairsClinical affairs 1 CRA/HN1 CRA/HN 9 CRC9 CRC
DataData management management1 Statistic PhD1 Statistic PhD2 Statistic MS2 Statistic MS
DataData management management1 Statistic PhD1 Statistic PhD2 Statistic MS2 Statistic MS
3 MD 3 MD 1 Pharmacist1 Pharmacist3 MD 3 MD 1 Pharmacist1 Pharmacist
CSMUH Chinese Medicine Clinical Trial CenterCSMUH Chinese Medicine Clinical Trial Center
04
Clinical Trials in CSMUH
Clinical trials in CSMUH
Clinical trials in CSMUH
Dr. Wei Global Trials ExperiencesDr. Wei Global Trials Experiences
About 60 trials in the past 5 years, 27 trials ongoing.About 60 trials in the past 5 years, 27 trials ongoing.**World top one enroller in **World top one enroller in
-Norvatis RHAK study: IL-17 MoAb in ankylosing spondylitis.-Norvatis RHAK study: IL-17 MoAb in ankylosing spondylitis.
-Pfizer: Etanercept in non-radiographic axial spondyloarthritis.-Pfizer: Etanercept in non-radiographic axial spondyloarthritis.
**Taiwan top one enroller in **Taiwan top one enroller in
-BMS IM101-174: Abatacept in rheumatoid arthritis-BMS IM101-174: Abatacept in rheumatoid arthritis
-UCB RA-0083: Anti-IL6 in rheumatoid arthritis-UCB RA-0083: Anti-IL6 in rheumatoid arthritis
-MSD MK0663-108: Etoricoxib in ankylosing spondylitis-MSD MK0663-108: Etoricoxib in ankylosing spondylitis
-Twi: IL-1 receptor antagonist in gouty arthritis-Twi: IL-1 receptor antagonist in gouty arthritis
-TSH: TuNex (Etanercept biosimilar) in rheumatoid arthritis-TSH: TuNex (Etanercept biosimilar) in rheumatoid arthritis
FDA inspectionFDA inspection CSMUH, Oct 18-20, 2010.CSMUH, Oct 18-20, 2010.
SLESLE
2020
21
CONFIDENTIAL July 2009
BLISS Phase 3 GeographyBLISS Phase 3 Geography
USUS
Puerto RicoPuerto Rico
CanadaCanada
MexicoMexico
Costa RicaCosta Rica
ArgentinaArgentina
BrazilBrazil
ChileChile
ColombiaColombia
PeruPeru
AustriaAustria
BelgiumBelgium
Czech RepublicCzech Republic
FranceFrance
GermanyGermany
IsraelIsrael
ItalyItaly
The NetherlandsThe Netherlands
PolandPoland
Romania/Romania/RomaniaRomania
RussiaRussia
SlovakiaSlovakia
SpainSpain
SwedenSweden
UKUK
AustraliaAustralia
Hong KongHong Kong
IndiaIndia
KoreaKorea
The PhilippinesThe Philippines
TaiwanTaiwan
1,693 patients from 223 centers in 31 countries1,693 patients from 223 centers in 31 countries
22
CONFIDENTIAL July 2009
Enrollment - BLISS-52
867 patients from 90 centers in 13 countries867 patients from 90 centers in 13 countries
Dr Wei Academia CreditsDr Wei Academia Credits
Steering committee and paper authorshipSteering committee and paper authorship• Etanercept in axial spondyloarthritisEtanercept in axial spondyloarthritis• Tofacitinib in ankylosing spondylitisTofacitinib in ankylosing spondylitis• ASAS classification criteria for SpondyloarthritisASAS classification criteria for Spondyloarthritis• Treating spondyloarthritis, including ankylosing Treating spondyloarthritis, including ankylosing
spondylitis and psoriatic arthritis, to target: spondylitis and psoriatic arthritis, to target: recommendations of an international task force.recommendations of an international task force.
International Advisory BoardInternational Advisory Board• Pfizer, EtanerceptPfizer, Etanercept• Abbvie, AdalimumabAbbvie, Adalimumab• UCB, Certolizumab PegolUCB, Certolizumab Pegol
My Investigator-Initiated StudiesMy Investigator-Initiated Studies1.1. Immunogenicity, Immunogenicity, adalimumab adalimumab levels and clinical response in ankylosing levels and clinical response in ankylosing
spondylitis patients during 24 weeks of follow-up. Annals Rheum Dis 2013spondylitis patients during 24 weeks of follow-up. Annals Rheum Dis 2013
2.2. Tramadol/acetaminophen combination (Ultracet) Tramadol/acetaminophen combination (Ultracet) as add-on therapy in the as add-on therapy in the treatment of patients with ankylosing spondylitis. Clin Rheumatol 2013treatment of patients with ankylosing spondylitis. Clin Rheumatol 2013
3.3. Efficacy and Safety of Efficacy and Safety of Herbal Medicine Yun-Cai Tea Herbal Medicine Yun-Cai Tea in the Treatment of in the Treatment of Hyperlipidemia: A Double-Blind Placebo-controlled Clinical Trial. Chinese Hyperlipidemia: A Double-Blind Placebo-controlled Clinical Trial. Chinese Journal of Integrative Medicine 2013Journal of Integrative Medicine 2013
4.4. A randomized, double-blind, placebo-controlled study to evaluate the A randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability ofefficacy and tolerability of Danshen (Salvia miltiorrhiza) Danshen (Salvia miltiorrhiza) as add-on anti-as add-on anti-hypertensive therapy in Taiwanese patients with uncontrolled hypertension. hypertensive therapy in Taiwanese patients with uncontrolled hypertension. Phytotherapy Research 2012 Phytotherapy Research 2012
5.5. Vitamin B6 Vitamin B6 supplementation improves pro-inflammatory responses in supplementation improves pro-inflammatory responses in patients with rheumatoid arthritis. Eur J Clin Nutr. 2010 patients with rheumatoid arthritis. Eur J Clin Nutr. 2010
6.6. Efficacy and immunomodulation of Efficacy and immunomodulation of Sterols/Sterolins Sterols/Sterolins in patients with in patients with allergic rhinitis: A randomized double blind placebo-controlled clinical trial. allergic rhinitis: A randomized double blind placebo-controlled clinical trial. Formosan Journal of Rheumatology 2009Formosan Journal of Rheumatology 2009
Consortium for Globalization of Consortium for Globalization of Chinese Medicine, CGCM Chinese Medicine, CGCM
OutlinesOutlines
1.1. Global clinical trials trendsGlobal clinical trials trends
2.2. CSMUH experiencesCSMUH experiences
3.3. Suggestions to sites, sponsors & health Suggestions to sites, sponsors & health authoritiesauthorities
Suggestions to SitesSuggestions to Sites IRB process IRB process
• CIRB/JIRB fast trackCIRB/JIRB fast track Contract processContract process
• Sponsor-Site template, DOH templateSponsor-Site template, DOH template Access to HIS, eg. Data mining, AlertAccess to HIS, eg. Data mining, Alert EMR EMR
• tracking system and CRA/CRC authenticationtracking system and CRA/CRC authentication More support to clinical trials More support to clinical trials
• Space, manpower, study fee usageSpace, manpower, study fee usage
Suggestions to SponsorsSuggestions to Sponsors
Bring more studies to Taiwan Bring more studies to Taiwan More budgetMore budget
• PI fee/ SC fee/ Lab testsPI fee/ SC fee/ Lab tests• Ask additional fee, eg. Feasibility survey fee, Ask additional fee, eg. Feasibility survey fee,
Overhead fee, start-up fee, SAE reporting feeOverhead fee, start-up fee, SAE reporting fee Recruitment network and advertisingRecruitment network and advertising Support on PI-initiated studiesSupport on PI-initiated studies
Suggestions to DOHSuggestions to DOH
DOH/CDE processDOH/CDE process IRB evaluationIRB evaluation Template of clinical trials contractTemplate of clinical trials contract Researcher network or consortiumResearcher network or consortium Bridging rules to ChinaBridging rules to China TCM licenses need clinical trialsTCM licenses need clinical trials All doctors can prescribe TCM All doctors can prescribe TCM Health foods Health foods alsoalso need clinical trials need clinical trials
ConclusionsConclusions
1.1. Taiwan has strengths in clinical trials Taiwan has strengths in clinical trials quality and patients poolingquality and patients pooling
2.2. Clinical trials business is arisingClinical trials business is arising
3.3. Need to improve IRB/Contract processNeed to improve IRB/Contract process
4.4. Bridging regulations to China and Asia Bridging regulations to China and Asia countriescountries
5.5. TCM and health foods also need clinical TCM and health foods also need clinical trials to prove efficacy and safetytrials to prove efficacy and safety
Chung Shan Medical University Hospital Chinese Medicine Clinical Trial Center
Chung Shan Medical University HospitalChung Shan Medical University Hospital
Clinical Trial Center Clinical Trial Center
James Cheng-Chung Wei, M.D., Ph.D.
Taichung, Taiwan
[email protected], +886 975 128095