Clinical Research in Hong Kong - HKDU CME:...

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