About CRC


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About CRC

  1. 1. http//:www.crc.gov.my The Clinical Research Centre Ministry of Health (MOH) Dr. Lim Teck Onn FRCP, M.Stat Director, Network of CRC MOH
  2. 2. Contents The Clinical Research Centre MOH <ul><li>Who are we? </li></ul><ul><li>What do we do? And what are our accomplishments? </li></ul><ul><li>Where do we go from here? </li></ul>
  3. 3. Clinical Research Centre Ministry of Health <ul><li>Conceived in the 1990s as the clinical research arm of the MOH; first centre opened in HKL in 2000 . </li></ul><ul><li>It is one of 6 research institutes under the National Institutes of Health of the MOH </li></ul><ul><li>By 2010, the Network of CRCs comprises 17 centres in MOH hospitals. Also getting Private hospitals’ and Universities’ CRCs to affiliate with the Network </li></ul><ul><li>Key tasks are to develop </li></ul><ul><li>- the capacities to enable high quality clinical research </li></ul><ul><li>- Network of sites to provide ready access to a large pool of investigators & patients for research purpose </li></ul>
  4. 4. CRC’s vision & dual missions For the people’s health & wealth <ul><li>CRC’s vision is be leading clinical research organization in Asia </li></ul><ul><li>CRC is both a MOH and Govt organization </li></ul><ul><li>As part of the MOH , we share MOH’s broad public health </li></ul><ul><li>mission: “To Improve patients’ health outcomes through ethical and quality clinical research” </li></ul><ul><li>Public health research mission for people’s health </li></ul><ul><li>2. As a Government Research institute , we also share responsibility for Malaysia’s critical national mission……. Specifically, to contribute to the development of Malaysia as clinical research hub for the clinical research outsourcing industry” </li></ul><ul><li>Contract research mission for the people’s wealth </li></ul>
  5. 5. NATIONAL INSTITUTE OF HEALTH, MALAYSIA Institute for Medical Research (IMR) Institute of Public Health (IPH) Institute of Health Management (IHM) Clinical Research Centre (CRC) Institute for Health System Research (IHSR) Institute of Health Promotion (IHP) National Institute For Natural Products and Vaccinology NATIONAL INSTITUTES OF HEALTH
  6. 6. Location of CRCs in Malaysia * * * * * * * * * * * * * * * * * *
  7. 7. So what does the CRC do? Four inter-related tasks 1. Develop Research capacity 2. Develop Data Resources 3. Promote & manage Contract Research 4. Support Investigator Initiated Research
  8. 8. 1. Develop Research Capacity # Research capacity Status 1 Research Governance & Ethics Esp. human subject protection & data confidentiality Ongoing efforts developing governance framework, structure & culture. 2 Domain expertise MOH investigators 3 Methods & protocol Core competency 4 Project management & Research QA Core competency 5 Information Tech . key enabling tool for Clinical Res., like Lab for Biomedical research <ul><li>Document Mgt System </li></ul><ul><li>Res. & Publication Repository </li></ul><ul><li>Part 11 Clinical Trial systems </li></ul><ul><li>IVRS Central Randomization </li></ul><ul><li>Information security tech. </li></ul>6 Data management In-house/ Outsourced 7 Biostatistics In-house/ Outsourced 8 Medical writing & Publishing In-house/ Outsourced 9 Specialized functions: Clinical Lab, Safety, Logistics, etc Outsourced
  9. 9. <ul><li>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. </li></ul>Investigator Sites Regulators Safety Surveillance Data Queries/Report Enrollment Scheduling Safety Data Protocols / Queries Submissions, etc. S. Adverse Reactions Clinical Supplies Lab Coordinator Samples Data Orders Kits Results Queries Subjects Monitors Data Data Management Multidisciplinary Team
  10. 10. Human resource & Best practices Human resource Training Best practice std Clinician scientist MD. PhD. GRP Scientific stds. GRP Investigators MD. GCP, GRP GCP, Helsinki Bioethicist/ IRB pro. Bioethics, IRB admin Helsinki, GCP, GRP, CIOMS Clinical Epi. MDs and PhDs Scientific stds, GEP Clinical Trialist MDs and PhDs Scientific stds, ICH E series CRM/ CRA CCRA GCP Study Coordinator SRN, CCRC GCP Safety surveillance Pharmacy E2, MedDRA Trial Supplies Pharmacy GMP (Annex 13) Info Tech (IT) Industry cert. Part 11, ISPE, ISO2700 Data mgt CCDM E6, E9, GDMP Lab MD Path, MLT GCLP (BARQA) Biostatistics PhDs ICH E9 and PSI, GSP Economics PhDs Scientific stds Medical writer MDs and PhDs ICH E3, ICMJE
  11. 11. Develop Human capital for Clinical Research <ul><li>Methodologic : Research methods, Biostatistics, Health Economics, etc </li></ul><ul><li>Ethics of Clinical Research for IRB members & Investigators </li></ul><ul><li>Good Clinical Practice ( GCP ) certification course </li></ul><ul><li>ACRP certification program for CRAs & Nurses </li></ul><ul><li>Biotech Corp’s Internship program </li></ul>
  12. 12. Clinical Research Conference
  13. 13. 2. Develop Data Resources <ul><li>Malaysian healthcare suffers from serious scarcity of healthcare data to inform policy & research </li></ul><ul><li>How many Malaysian children visited their GPs for asthmatic wheeze in 2008? How are they treated? </li></ul><ul><li>How many Malaysian women had mastectomy in 2006? How many went to get Herceptin? And how alive 5 years later? </li></ul><ul><li>How many Malaysian men had heart attack in 2008? With what outcomes? </li></ul><ul><li>etc </li></ul><ul><li>Two proven tools to produce the statistics: </li></ul><ul><li>Patient registries </li></ul><ul><li>Healthcare surveys </li></ul>
  14. 14. Patient registry & Healthcare survey <ul><li>These are organized information system </li></ul><ul><li>to collect, process, report and use both clinical service and individual patient level data for policy, clinical and research purposes </li></ul><ul><li>Healthcare surveys target healthcare providers in Malaysia; while registry targets a specific patient population (defined by disease or therapy) </li></ul><ul><li>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 </li></ul>
  15. 15. Patient registers & Healthcare surveys supported by CRC # Patient registries Healthcare surveys 1 National Renal Registry National Suicide Registry M’sian Cardio-Thoracic Registry Healthcare Establishment & Workforce Survey 2 National Transplant Registry Nat. CVD ( ACS/ PCI ) Database National Neurology Registry Health professional registers 3 National Eye Database Nat. Dermatology Registry National Chest Registry National Medicines Use Survey 4 Malaysian National Neonata l Registry National Cancer Patient Registry National Urology Registry National Medical Device Survey 5 Malaysian Liver Registry Hematological Malignancy Reg. National ORL Registry National Medical care Survey 6 Malaysian GI Registry National OT Register National Nuclear Medicine Database JPN National Death Register 7 National Trauma Database Malaysian Registry of Intensive Care National Radiology Registry Post-Operative Mortality Review 8 Diabetes Registry of Malaysia Nat. Inflammatory Arthritis Registry National O&G Patient Registry Maternal Mortality Register 9 National Mental Health Registry Nat. Orthopedic Reg Malaysia National Paediatric Mortality Register
  16. 16. Statistical reports from patient registries
  17. 17. Healthcare Statistics Drugs, Med. Technology, Health Service, Facilities & Workforce # Healthcare Surveys 1 National Healthcare Establishment & Workforce Surveys (NHEWS) ( NEW) 2 National Medical Care Survey (NMCS) ( NEW) 3 National Medicines Use Survey 4 National Medical Device Survey
  18. 18. 3. Develop Contract Research Industry <ul><li>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 </li></ul><ul><li>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 </li></ul><ul><li>And increasingly Pharma/Biotech industries or their CROs are also o ffshoring clinical trials to emerging markets, including Asia </li></ul><ul><li>“ 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 </li></ul>
  19. 19. “ Asian CRO markets (Phase I–IV) earned revenues of $1.2 billion in 2006” Frost & Sullivan report Oct 2007
  20. 20. Malaysian government commitment to Contract Clinical Research <ul><li>“ To drive industrialization to a higher level of global competitiveness…. </li></ul><ul><li>… this is a critical endeavor for our national mission to attain developed nation status under Vision 2020” </li></ul><ul><li>Dato’ seri Abdullah Badawi, Prime Minister of Malaysia </li></ul>… Contract Clinical Research is a targeted industry in IMP3
  21. 21. Malaysia as clinical trial hub in Asia 17/11/2009
  22. 22. Industry Statistics Measure Y2005 Y2008 Y2009 Y2014 (p) New trials 64 125 92 200 # Sites ND 367 352 1000 # patients ND 6390 3573 12,000 Revenue, Million RM ND 160 110 350 # MMC conducting trials in Malaysia ND 33 30 50 # International CROs operating in Malaysia ND 11 10 20 # Int. CRO based in M’sia 0 2 6 10 # Local CROs 0 2 4 6 # GCP cert. investigators ND ND 1010 3000 # Site Coordinator (SRN) ND ND 1200 3500 # Clinical Trial Admin ND ND 35 350 # CRA/ CRM ND ND 110 350
  23. 23. What are our competitive strengths? <ul><li>1. Committed government support to develop </li></ul><ul><li>the contract research industry </li></ul><ul><li>2. Robust Regulatory environment </li></ul><ul><li>Enforcement of compliance with GCP/ GLP </li></ul><ul><li>Intellectual property protection regime </li></ul><ul><li>Fast timelines for ethics review & regulatory approval (IND/CTX) </li></ul><ul><li>3. Conducive Clinical Research environment : </li></ul><ul><li>Qualified and well trained medical professionals who are English literate, and working in modern medical facilities </li></ul><ul><li>Supported by local CRCs & dedicated clinical research coordinators (SRNs) </li></ul><ul><li>Large patient population , especially diabetes, cancer, heart diseases and hepatitis, from d iverse multi-ethnic culture </li></ul><ul><li>Low cost advantage </li></ul><ul><li>Efficient logistics for trial supplies & biospecimen </li></ul><ul><li>Availability of competent CROs </li></ul>
  24. 24. Strategic plan for CRO industry in M’sia <ul><li>Four key actions under RM10 </li></ul><ul><li>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 </li></ul><ul><li>Increase required human capital </li></ul><ul><li>Incentivize MOH health professionals (doctors, pharmacists, nurses etc.) </li></ul><ul><li>Human subject protection : Stringent and independent review & ongoing oversight </li></ul>
  25. 25. 4. Investigator Initiated Research (IIR/ IIT) <ul><li>Original clinical research work initiated and conducted by Malaysian investigators to: </li></ul><ul><li>F ill critical knowledge gap relevant to Malaysian public health </li></ul><ul><li>E nhance Malaysia’s contribution to the clinical evidence base, especially in disease & therapy areas relevant to our population’s health </li></ul>
  26. 26. CRC Research Publication Output Type of investigations ranged from case reports, clinical trials , healthcare quality, health outcomes, clinical epidemiology & health economics Year # journal publications # publications in JIF>1 # research or registry reports 2002 4 4 0 2006 16 11 (69%) 2 2007 18 11 (69%) 2 2008 42 12 (28%) 14 2009 49 19 (37%) 13
  27. 27. <ul><li>A Randomised trial to establish the therapeutic equivalence between Carex ® and Ultra ® in patients on CAPD. Peritoneal Dialysis International 2003 </li></ul><ul><li>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 </li></ul><ul><li>An Open Labeled, Multicentre, Randomised Phase II Trial of Mycophenolate Mofetil (CellCept ®) for the Treatment of Severe Lupus Nephritis. Nephrology 2005 </li></ul><ul><li>A Randomised, Multi-center, Open label trial to establish the therapeutic equivalence between AndyDisc ® and Ultrabag ® in patients on CAPD. Am J Kidney Dis ease 2006 </li></ul><ul><li>A Randomized trial to establish the therapeutic equivalence between Eprex ® and a biogeneric epoetin GerEPO  in patients on Hemodialysis Nephrology 2007 </li></ul><ul><li>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, </li></ul><ul><li>A Randomized Controlled trial of Conversion to Generic Cyclosporine in Stable Renal Transplant recipients J Am Soc Nephrology 2007 </li></ul><ul><li>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 </li></ul><ul><li>Efficacy of Diosmectite  in Combination with Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children Clin Gastroenterology & Hepatology 2009 </li></ul><ul><li>Efficacy of Panobinostat in Patients with Relapsed/Refractory Hodgkin Lymphoma (HL) After High-Dose Chemotherapy with Autologous Stem Cell Transplant . Blood 2009 </li></ul><ul><li>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] </li></ul>Clinical Trial Publications from CRC “ The CRC publishes more clinical trials than all the universities put together in Malaysia”
  28. 28. Health Economics research Publications <ul><li>Economic Evaluation of Ministry of Health Cataract Surgery services. International J Ophthalmology 2004 </li></ul><ul><li>Eonomic Evaluation of Ministry of Health Neonatal Intensive Care services. J Perinatology 2005 </li></ul><ul><li>Economic Evaluation of Centre Haemodialysis and Continuous Ambulatory Peritoneal Dialysis in Ministry of Health Hospitals, Malaysia. Nephrology 2005 </li></ul><ul><li>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 </li></ul><ul><li>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 </li></ul><ul><li>Public and Private Roles in improving access to dialysis therapy in a developing country: Empirical data from Malaysia. [pending Health Affairs ] </li></ul>“ The CRC publishes more health economics research than any other research institutions in Malaysia”
  29. 29. Selected publications from observational studies 1 <ul><li>Bimodality in Blood Glucose distribution: is it universal? Diabetes Care 2002 </li></ul><ul><li>Assessing Doctors’ performance: Application of CUSUM technique in monitoring doctor’s performance. Int J Quality in Health Care 2002 </li></ul><ul><li>Prevalence of blindness and low vision in Malaysian population: Results from the National Eye Survey 1996 . Br J Ophthalmol 2002 </li></ul><ul><li>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 </li></ul><ul><li>Prevertebral Soft Tissue Measurements in Thyroid Enlargement: The value of Lateral Neck Radiographs. Asian J Surgery 2004 </li></ul><ul><li>Refractive error and Visual impairment in Schoolchildren in Gombak Malaysia. Ophthalmology 2005 </li></ul><ul><li>Non-compliance with the re-excision guidelines for cutaneous melanoma in The Netherlands does not influence survival Eur J Surg Oncology 2006 </li></ul><ul><li>A comparative study of autorefraction and subjective refraction with and without cycloplegia in primary school children. subjective refraction. American J Ophthalmology 2006 </li></ul><ul><li>The enigma of hypertensive ESRD: Incidence and Trends in 18 European, Canadian and Asia-Pacific populations 1998-2002. Am J Kidney Dis 2006 </li></ul><ul><li>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 </li></ul><ul><li>Accuracy Of 64 Row Multi Detector Computed Tomography In Detecting Coronary Artery Disease in 134 Symptomatic Patients : Influence of Calcification. Am Heart Journal 2006 </li></ul>
  30. 30. Selected publications from observational studies 2 <ul><li>Platelet non-responsiveness among diabetes patients in relation to coronary artery disease. International J Cardiology 2007 </li></ul><ul><li>Epidemiology of intussusception in Malaysia: A multi-center 3 year review . SE Asian Journal of Tropical Medicine and Public Health 2008 </li></ul><ul><li>Use of renal registry data for research, healthcare planning and quality improvement. What can we learn from registry data? Nephrology 2008 </li></ul><ul><li>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 </li></ul><ul><li>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 </li></ul><ul><li>Demography and Clinical Course of Ulcerative Colitis in a Multiracial Asian Population: A Nationwide Study From Malaysia. J Digestive Disease 2009 </li></ul><ul><li>Radiofrequency coblation for chronic foot and ankle tendinosis. Journal of Orthopaedic Surgery 2009 </li></ul><ul><li>CUSUM: A dynamic tool for monitoring competency in cataract surgery performance. British Journal of Ophthalmology 2009 </li></ul>
  31. 31. Where do we go from here? <ul><li>Contract research : Corporatized under RM10, incentive for MOH health professionals, but need to strengthen human subject protection </li></ul><ul><li>Data resources : Need assured funding support, better access to available data sources, strengthen IT and statistical capabilities </li></ul><ul><li>Investigator initiated research : More original work, better supported investigators, more competitive grant awards </li></ul>
  32. 32. Strengthening research collaboration <ul><li>Network of CRCs in Malaysia: MOH+ University+ Private sectors </li></ul><ul><li>Cooperative Clinical Research Groups (CRG) </li></ul><ul><li>Public-Private partnership : engaging private sector partners </li></ul><ul><li>Biotech Corp & MIDA: Working with other government agencies with overlapping responsibility </li></ul><ul><li>International linkages </li></ul>
  33. 33. Thank You www.crc.gov.my