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Clinical Research in Malaysia

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The Clinical Research Centre Ministry of Health (MOH) Dr. Lim Teck Onn FRCP, M.Stat Director, Network of CRC MOH http//:www.crc.gov.my Contents The Clinical Research ... – PowerPoint PPT presentation

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Title: Clinical Research in Malaysia


1
The Clinical Research Centre Ministry of Health
(MOH)
Dr. Lim Teck Onn FRCP, M.Stat Director, Network
of CRC MOH
http//www.crc.gov.my
2
ContentsThe Clinical Research Centre MOH
  • Who are we?
  • What do we do? And what are our accomplishments?
  • Where do we go from here?

3
Clinical Research Centre Ministry of Health
  • Conceived in the 1990s as the clinical research
    arm of the MOH first centre opened in HKL in
    2000.
  • It is one of 6 research institutes under the
    National Institutes of Health of the MOH
  • By 2010, the Network of CRCs comprises 17 centres
    in MOH hospitals. Also getting Private hospitals
    and Universities CRCs to affiliate with the
    Network
  • Key tasks are to develop
  • - the capacities to enable high quality clinical
    research
  • - Network of sites to provide ready access to a
    large pool of investigators patients for
    research purpose

4
CRCs vision dual missionsFor the peoples
health wealth
  • CRCs vision is be leading clinical research
    organization in Asia
  • CRC is both a MOH and Govt organization
  • As part of the MOH, we share MOHs broad public
    health
  • mission To Improve patients health outcomes
    through ethical and quality clinical research
  • Public health research mission for peoples
    health
  • 2. As a Government Research institute, we also
    share responsibility for Malaysias critical
    national mission. Specifically, to contribute
    to the development of Malaysia as clinical
    research hub for the clinical research
    outsourcing industry
  • Contract research mission for the peoples wealth

5
NATIONAL INSTITUTE OF HEALTH, MALAYSIA
NATIONAL INSTITUTES OF HEALTH
Institute of Public Health (IPH)
Clinical Research Centre (CRC)
Institute of Health Promotion (IHP)
Institute for Medical Research (IMR)
National Institute For Natural Products and
Vaccinology
Institute of Health Management (IHM)
Institute for Health System Research (IHSR)
6
Location of CRCs in Malaysia


















7
So what does the CRC do?
Four inter-related tasks
8
1. Develop Research Capacity
9
Subjects
Multidisciplinary Team
Lab Coordinator
Data Management
Data
Safety Surveillance
Queries
Samples
Data
Enrollment Scheduling
Queries/Report
Results
Safety Data
Data
Submissions, etc.
S. Adverse Reactions
Protocols / Queries
Monitors
Kits
Investigator Sites
Orders
Regulators
Clinical Supplies
  • The design and conduct of modern clinical
    research is a complex undertaking. It requires
    many professionals from diverse disciplines to
    perform the variety of work processes involved.

10
Human resource Best practices
11
Develop Human capital for Clinical Research
  • Methodologic Research methods, Biostatistics,
    Health Economics, etc
  • Ethics of Clinical Research for IRB members
    Investigators
  • Good Clinical Practice (GCP) certification course
  • ACRP certification program for CRAs Nurses
  • Biotech Corps Internship program

12
Clinical Research Conference
13
2. Develop Data Resources
  • Malaysian healthcare suffers from serious
    scarcity of healthcare data to inform policy
    research
  • How many Malaysian children visited their GPs for
    asthmatic wheeze in 2008? How are they treated?
  • How many Malaysian women had mastectomy in 2006?
    How many went to get Herceptin? And how alive 5
    years later?
  • How many Malaysian men had heart attack in 2008?
    With what outcomes?
  • etc
  • Two proven tools to produce the statistics
  • Patient registries
  • Healthcare surveys

14
Patient registry Healthcare survey
  • These are organized information system
  • to collect, process, report and use both clinical
    service and individual patient level data for
    policy, clinical and research purposes
  • Healthcare surveys target healthcare providers in
    Malaysia while registry targets a specific
    patient population (defined by disease or
    therapy)
  • It employs survey methods to collect uniform data
    on clinical services in the country and
    observational study methods to collect uniform
    patient level data to evaluate the treatment and
    health outcomes

15
Patient registers Healthcare surveys supported
by CRC
16
Statistical reports from patient registries
17
Healthcare Statistics Drugs, Med. Technology,
Health Service, Facilities Workforce
18
3. Develop Contract Research Industry
  • The pharmaceutical, biotechnology, and
    medical-device industries must constantly
    discover and develop innovative therapeutic
    products (drugs or devices), and invest hugely in
    research new product development
  • Contract Clinical Research Industry has emerged
    over the last 20 years to serve the
    Pharma/Biotech industries by providing more
    efficient (faster time to market) and cost
    effective (cheaper) clinical development
    services. This is called Clinical Trial
    Outsourcing
  • And increasingly Pharma/Biotech industries or
    their CROs are also offshoring clinical trials
    to emerging markets, including Asia
  • Within two to three years, up to 65 of FDA
    regulated clinical trials for top pharmaceutical
    companies will be conducted abroad. Tufts
    Outlook 2007 Report, 3 January 2007

19
Asian CRO markets (Phase IIV) earned revenues
of 1.2 billion in 2006 Frost Sullivan report
Oct 2007
20
Malaysian government commitment to Contract
Clinical Research
  • To drive industrialization to a higher level of
    global competitiveness.
  • this is a critical endeavor for our national
    mission to attain developed nation status under
    Vision 2020
  • Dato seri Abdullah Badawi, Prime Minister of
    Malaysia

Contract Clinical Research is a targeted
industry in IMP3
21
Malaysia as clinical trial hub in Asia
17/11/2009
22
Industry Statistics
23
What are our competitive strengths?
  • 1. Committed government support to develop
  • the contract research industry
  • 2. Robust Regulatory environment
  • Enforcement of compliance with GCP/ GLP
  • Intellectual property protection regime
  • Fast timelines for ethics review regulatory
    approval (IND/CTX)
  • 3. Conducive Clinical Research environment
  • Qualified and well trained medical professionals
    who are English literate, and working in modern
    medical facilities
  • Supported by local CRCs dedicated clinical
    research coordinators (SRNs)
  • Large patient population, especially diabetes,
    cancer, heart diseases and hepatitis, from
    diverse multi-ethnic culture
  • Low cost advantage
  • Efficient logistics for trial supplies
    biospecimen
  • Availability of competent CROs

24
Strategic plan for CRO industry in Msia
  • Four key actions under RM10
  • Corporatized Entity (100 govt owned like Health
    Tourism Council, Health promotion board) to
    manage contract research Marketing business
    development, hire retain industry talents,
    partner commercial CROs/SMOs etc
  • Increase required human capital
  • Incentivize MOH health professionals (doctors,
    pharmacists, nurses etc.)
  • Human subject protection Stringent and
    independent review ongoing oversight

25
4. Investigator Initiated Research (IIR/ IIT)
  • Original clinical research work initiated and
    conducted by Malaysian investigators to
  • Fill critical knowledge gap relevant to Malaysian
    public health
  • Enhance Malaysias contribution to the clinical
    evidence base, especially in disease therapy
    areas relevant to our populations health

26
CRC Research Publication Output
Type of investigations ranged from case reports,
clinical trials, healthcare quality, health
outcomes, clinical epidemiology health economics
27
Clinical Trial Publications from CRC
The CRC publishes more clinical trials than all
the universities put together in Malaysia
  • A Randomised trial to establish the therapeutic
    equivalence between Carex and Ultra in patients
    on CAPD. Peritoneal Dialysis International 2003
  • A Multi-center, Open label, Randomized Controlled
    Efficacy study of Direct Coronary stenting
    comparing to Conventional stenting in Diabetic
    patients undergoing Elective angioplasty for
    Coronary Artery Disease (DECIDE trial). Am Heart
    J 2004
  • An Open Labeled, Multicentre, Randomised Phase II
    Trial of Mycophenolate Mofetil (CellCept) for
    the Treatment of Severe Lupus Nephritis.
    Nephrology 2005
  • A Randomised, Multi-center, Open label trial to
    establish the therapeutic equivalence between
    AndyDisc and Ultrabag in patients on CAPD. Am J
    Kidney Disease 2006
  • A Randomized trial to establish the therapeutic
    equivalence between Eprex and a biogeneric
    epoetin GerEPO? in patients on Hemodialysis
    Nephrology 2007
  • A randomised study comparing the efficacy and
    safety of rosuvastatin with atorvastatin for
    achieving lipid goals in clinical practice in
    Asian patients at high risk of cardiovascular
    disease (DISCOVERY-Asia study). Curr Med Res Opin
    2007,
  • A Randomized Controlled trial of Conversion to
    Generic Cyclosporine in Stable Renal Transplant
    recipients J Am Soc Nephrology 2007
  • An Observational Cohort Study to determine the
    long-term Safety and Efficacy of GerEPO for the
    treatment of renal anaemia in patients with
    Chronic Kidney Disease. Nephrology 2009
  • Efficacy of Diosmectite? in Combination with Oral
    Rehydration in the Treatment of Acute Watery
    Diarrhoea in Infants and Children Clin
    Gastroenterology Hepatology 2009
  • Efficacy of Panobinostat in Patients with
    Relapsed/Refractory Hodgkin Lymphoma (HL) After
    High-Dose Chemotherapy with Autologous Stem Cell
    Transplant. Blood 2009
  • A Randomized Controlled Trial to Evaluate the
    Efficacy of a Community-based Cardiovascular Risk
    Factors Intervention Strategies (CORFIS Trial) in
    managing Hypertension in the Primary Care Setting
    Submitted

28
Health Economics research Publications
The CRC publishes more health economics research
than any other research institutions in Malaysia
  • Economic Evaluation of Ministry of Health
    Cataract Surgery services. International J
    Ophthalmology 2004
  • Eonomic Evaluation of Ministry of Health Neonatal
    Intensive Care services. J Perinatology 2005
  • Economic Evaluation of Centre Haemodialysis and
    Continuous Ambulatory Peritoneal Dialysis in
    Ministry of Health Hospitals, Malaysia.
    Nephrology 2005
  • An Asian regional analysis of Cost-Effectiveness
    of early Irbesartan treatment versus Concentional
    Anti-Hypertensive, late Amlodipine, and Late
    irbesartan Treatments in patients with Type 2
    Diabetes, hypertension and Nephropathy. Value in
    Health 2007
  • Geographic equity in distribution of scarce
    dialysis resources in Malaysia. pp. 143-156 In
    Promoting Health and Equity Evidence, Policy and
    Action -   Cases from the Western Pacific Region
    WHO Regional Office for the Western Pacific March
    2009, 168 pages ISBN 9879290614272
  • Public and Private Roles in improving access to
    dialysis therapy in a developing country
    Empirical data from Malaysia. pending Health
    Affairs

29
Selected publications from observational studies
1
  • Bimodality in Blood Glucose distribution is it
    universal? Diabetes Care 2002
  • Assessing Doctors performance Application of
    CUSUM technique in monitoring doctors
    performance. Int J Quality in Health Care 2002
  • Prevalence of blindness and low vision in
    Malaysian population Results from the National
    Eye Survey 1996. Br J Ophthalmol 2002
  • Cross-cultural Adaptation and Validation of the
    English Version of the International Index of
    Erectile Function (IIEF) for Use in Malaysia. Int
    J Impotence Research/ Journal of Sexual Medicine
    2003
  • Prevertebral Soft Tissue Measurements in Thyroid
    Enlargement The value of Lateral Neck
    Radiographs. Asian J Surgery 2004
  • Refractive error and Visual impairment in
    Schoolchildren in Gombak Malaysia. Ophthalmology
    2005
  • Non-compliance with the re-excision guidelines
    for cutaneous melanoma in The Netherlands does
    not influence survival Eur J Surg Oncology 2006
  • A comparative study of autorefraction and
    subjective refraction with and without
    cycloplegia in primary school children.
    subjective refraction. American J Ophthalmology
    2006
  • The enigma of hypertensive ESRD Incidence and
    Trends in 18 European, Canadian and Asia-Pacific
    populations 1998-2002. Am J Kidney Dis 2006
  • Geographic, ethnic, age-related and temporal
    variation in the incidence of ESRD in Europe,
    Canada and the Asia-pacific, 1998-2002. Nephrol
    Dial Transplant 2006
  • Accuracy Of 64 Row Multi Detector Computed
    Tomography In Detecting Coronary Artery Disease
    in 134 Symptomatic Patients Influence of
    Calcification. Am Heart Journal 2006

30
Selected publications from observational studies 2
  • Platelet non-responsiveness among diabetes
    patients in relation to coronary artery disease.
    International J Cardiology 2007
  • Epidemiology of intussusception in Malaysia A
    multi-center 3 year review. SE Asian Journal of
    Tropical Medicine and Public Health 2008
  • Use of renal registry data for research,
    healthcare planning and quality improvement. What
    can we learn from registry data? Nephrology
    2008
  • Optimal cut-off levels to define obesity
    Relation between BMI and waist circumference and
    CVD, dyslipidaemia, hypertension and diabetes in
    Malaysia AP J Clinical Nutrition 2009
  • Establishing learning curve for Tenckhoff
    catheter insertion by interventional
    nephrologists by using CUSUM analysis How many
    procedures and in which situation?  Seminar in
    Dialysis 2009
  • Demography and Clinical Course of Ulcerative
    Colitis in a Multiracial Asian Population A
    Nationwide Study From Malaysia. J Digestive
    Disease 2009
  • Radiofrequency coblation for chronic foot and
    ankle tendinosis. Journal of Orthopaedic Surgery
    2009
  • CUSUM A dynamic tool for monitoring competency
    in cataract surgery performance. British Journal
    of Ophthalmology 2009

31
Where do we go from here?
  • Contract research Corporatized under RM10,
    incentive for MOH health professionals, but need
    to strengthen human subject protection
  • Data resources Need assured funding support,
    better access to available data sources,
    strengthen IT and statistical capabilities
  • Investigator initiated research More original
    work, better supported investigators, more
    competitive grant awards

32
Strengthening research collaboration
  • Network of CRCs in Malaysia MOH University
    Private sectors
  • Cooperative Clinical Research Groups (CRG)
  • Public-Private partnership engaging private
    sector partners
  • Biotech Corp MIDA Working with other
    government agencies with overlapping
    responsibility
  • International linkages

33
Thank You
www.crc.gov.my
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