clinical research in hong kong - hkdu cme:...
TRANSCRIPT
Hong Kong Doctors Union Sunday Afternoon Symposium 1st February, 2015
Clinical Research in Hong Kong - and the Potential Development in the Private Healthcare Sector
Henry Yau BSc (Biochemistry), MBA (Finance)
• Managing Director Clinical Trials Centre, HKU
• Independent Member HA HTW Cluster Research Ethics Committee
• Member Consortium on Harmonization of Institutional Requirements for Clinical Research (CHAIR)
• Member Clinical Trials Task Force, Hong Kong Association of the Pharmaceutical Industry (HKAPI)
• Co-chief Trainer Professional Research Accreditation for Clinical Trials Investigative Site Executives (PRACTISE)
• Advisor, Asia Training and Resources in Research Ethics Evaluation (TRREE)
Clinical Research in Hong Kong
- and the Potential Development in the Private Healthcare Sector
Highlights :
• Clinical Practice & Clinical Research
• Classification of Clinical Studies
• Clinical Research Activities in Hong Kong
• Research Ethics Committee
• Research Personnel & Facilities
• Research Compliance & Training
• Support by HKU Clinical Trials Centre
Clinical Practice & Clinical Research
Address
Unmet Medical
Needs
Through
Clinical Research
What is clinical research/trial ?
Human
Beings
Research
Questions (e.g. efficacy of
drugs, devices or
procedures)
Observation
& Data
Collection
Analysis &
Conclusion
Clinical Practice VS Clinical Research
Clinical Practice Clinical Research
Main Objective • Treatment of patients • Answer research questions
Targeted
Population
• Whole patient population • Selected patients only
(Sampling)
Operating
Environment
• Real world environment • Controlled environment
(to avoid interference by
unwanted factors)
Process &
Judgment
• Clinicians’ professional
judgment
• Knowledge + Experience
(Science + Art)
• Pre-defined in study
protocols
• Little judgment by
investigators
Regulations • On medical products
• On medical professionals
• On medical products
• On research process
Documentation • Only for patient follow-up • Long-term archiving
• Retrievable & verifiable
• Clinical
Services
• Training &
Education
• Research
Professor John Leong Chairman, Hospital Authority, HK
Value of Clinical Research to Healthcare System
Scientific & Academic
Merits
Benefits to Patients & Healthcare
Training Opportunities
International Reputation
Extra Funding & Resources
Value of
Clinical
Research
Value of Clinical Research to Doctors
Classification of Clinical Studies
Classification of Clinical Studies
By Research Item
Drugs
Devices
Cell Therapies
Gene Therapies
Herbal Medicines
Alternative Medicines
Health Supplements
Procedures/Methods
Risk Regulation Study
Design
By Intervention
Non-interventional Interventional
Classification of Clinical Studies
By Time Horizon
Prospective Retrospective
Clinical Risk
Classification of Clinical Studies
By Responsible Party
Classification of Clinical Studies
Clinical Research Activities
in Hong Kong
Clinical Study Sites in Hong Kong
- Public hospitals
- Universities
- Private hospitals
- Private clinics
* All numbers updated on
7 Jan 2015
Industry-
Sponsored
Studies
Investigator-
initiated
Studies
Total
Confirmed Studies (a) 824 78 902
Closed Studies (b) 596 12 608
Active Studies (c)=(a)-(b) 228 66 294
Studies to be Initiated (d) 84 33 117
Active Study Files (c)+(d) 312 99 411
Reference from HKU-CTC’s Track Records
32%
6%
8%
11%
16%
27%
Therapeutic Area
20%
6%
48%
21%
5%
Study Phase
Oncology
Cardiology
GI & Hepatology
Endocrinology
Haematology
Others
Phase 1
Phase 2
Phase 3
Phase 4
Others
Reference from HKU-CTC’s Track Records
Potential Clinical Research in Private Sector
• Mild to moderate diseases
• Chronic diseases
• Epidemiology research
• Vaccine studies
Challenges of Clinical Research in the Private Sector
Research Personnel &
Facilities
Research Ethics
Committee
Compliance & Training
Research Ethics Committee
Clinical Research
Issues
Scientific, Medical &
Ethical Issues
Legal Issues
Responsibility of a REC
Independent evaluation
No authority to override legal requirements
Public Research Ethics Committee System in HK
Joint CUHK-
NTEC CREC
HKU/HA
HKW IRB
NTWC
CREC
HKE
CREC
KC/KE
REC KWC-REC
Private Research Ethics Committees in HK
Hong Kong
Clinical Research
Ethics Committee
RECs affiliated
with individual
private
hospitals
Research Personnel & Facilities
Clinical
Trial
Collection
Data
Sponsor &
Contractors
Study Site
Regulatory
Bodies
Investigators & Other Clinical Research Players
Investigator
Regulatory
Agency
Other
Research
Personnel
Service
Units
Sponsor
CRO
Subject /
Patient
REC
Manage investigational product
Follow study protocol
Attend meetings
Complete CRFs
Perform informed consent
Obtain ethics approval
Provide medical care
Report adverse events
Keep records Perform study procedures
Recruit subjects/patients Submit progress reports
Principal Investigator
Study Team
Principal Investigator / Sub-investigators
Study Coordinators / Research Nurses / Research Assistants
Pharmacists / Dispensers
Laboratory Technologists / Technicians
Radiologists / Radiographers
and many more ……
Study Facilities
• Outpatient clinics
• Hospital wards
Study Facilities
• Suitable facilities/equipment
• Maintenance & repair
• Backup equipment
• Power supply
• Document Storage
• Collaboration with
laboratories/imaging centres
• Outpatient clinics
• Hospital wards
Research Compliance & Training
• Clinical research protocol
• Concepts of clinical research ethics
• Good clinical practice (GCP)
• Local regulatory requirements
• REC requirements
• Research operations & management
Clinical Research Compliance
Research Personnel &
Facilities
Research Ethics
Committee
Compliance & Training
How to overcome the challenges ?
For more
information about
HKU-CTC, please
visit our website at
www.hkuctc.com
HKU-CTC Website
Full-Service Academic Research Organization
HKU CTC
SMO
Training CRO
Site
Management
Services
Contract
Research
Services
Professional
Training
Services
Support by HKU-CTC
CRO Services
SMO Services
Protocol
Development
Project
Planning
Regulatory
Submission
CRF & EDC
Development
Study
Initiation
Project Management
Study Monitoring
Data Management
Data
Cleaning &
Locking
Statistical
Analysis
CSR
Preparation
Scientific
Publication
Feasibility
Assessment
Ethics
Submission
Budgeting
Contract
Negotiation
Study
Initiation
Project Coordination
Ethics Affairs
Study Coordinator Support
Drug Management
Specimen Management
Payment Management
Contract Management
Data
Queries
Resolution
Final Report
to IRB &
Regulatory
Authority
Scientific
Publication
A comprehensive training
program specifically
designed for
investigators and
study site personnel
worldwide
Professional Research Accreditation for Clinical Trials Investigative Site Executives
Training: PRACTISE
25 elective modules
Practical sessions
Training: PRACTISE
Training programs that fulfill TransCelerate’s
minimum criteria can be recognized by its
member companies, and may not be required to
attend their own GCP training programs.
Training: PRACTISE
Egypt
Malaysia
Taiwan
Hong Kong
Macau
Dubai
Mainland China
Vietnam
Professional Research Accreditation for Clinical Trials Investigative Site Executives
PRACTISE Workshops
Egypt Sep 2012
Dubai May 2013/Sep 2014
Taiwan Jun/Nov 2013 (N=3)
Vietnam Jan 2013
China Nov 2014 (N=4)
Hong Kong 2010-2014 (N=13)
Hong Kong Nov 2014
International
Strategic Collaboration
with Switzerland
On-line Learning: TRREE
E-Learning platform on
clinical research ethics
Free-of-charge
HKU CTC will develop a
mainland Chinese
version
HKU CTC will develop a
Hong Kong local
supplement
HKU CTC
is a major
contributor
www.TRREE.org
On-line Learning: TRREE
You don’t need to be Einstein to do research !
Clinical research is for your patients, your family & everybody!
Thank You