Viet Nam: a potential research sources for infectious diseases Tam Nguyen, Regional Manager Department of International Trials National Center of Global Health and Medicine
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Table of content Introduction to Vietnam Diversity of infectious diseases in Vietnam Investigator network and facilities Regulatory and management system Reasons to land clinical trials in Vietnam 3
Which picture is Vietnam? 4
Introduction to Vietnam Weather North: sub-tropical South: tropical Land areas 331,200 km 2 Population 93,5 million (2015) 305 people/km 2 Main cities Capital: Ha Noi (7.974 million est. in 2018) Financial hub: Ho Chi Minh City ( 8.992 million est. in 2018) Economy GDP per capital: $ 2,385 (2017) GDP growth: 6.6 % (est. from 2017 to 2026) 5
Introduction to Vietnam Healthcare system Government Province People Committee Ministry of Health (MOH) MOH Departments Research Institutes (NIHE, Pasteur Institutes, etc.) Medical Colleges National Hospitals (General and specialist) Provincial Health Bureaus Provincial Hospitals (General and Specialist) Provincial Preventive Medical Center Medical Secondary Schools District of People Committee District Health Centers Commune Prov. Committee Commune Health Centers 6
Introduction to Vietnam Healthcare system 7.5% Healthcare expenditure (%GDP) in 2017 86% Social health insurance coverage in 2017 76.0 Years of life expectancy in 2018 (rank 56 th in the World) 1346 Hospitals in Vietnam (1,161 public hospitals and 185 private hospitals in 2016) 7
Diversity of infectious diseases in Vietnam Oral- Airborne- Vector borne transmission distribution Blood-borne transmission diseases Emergence of resistant bacteria 8
Diversity of infectious diseases in Vietnam Oral-borne transmission distribution Reference: Phung D. et al. The effects of socioecological factors on variation of communicable diseases: A multiple-disease study at the national scale of Vietnam. PLoS One. 2018 Mar 1;13(3):e0193246. doi: 10.1371/journal.pone.0193246. ecollection 2018. 9
Diversity of infectious diseases in Vietnam Airborne - borne transmission distribution Reference: Phung D. et al. The effects of socioecological factors on variation of communicable diseases: A multiple-disease study at the national scale of Vietnam. PLoS One. 2018 Mar 1;13(3):e0193246. doi: 10.1371/journal.pone.0193246. ecollection 2018. 10
Diversity of infectious diseases in Vietnam Vector - borne transmission distribution Reference: Phung D. et al. The effects of socioecological factors on variation of communicable diseases: A multiple-disease study at the national scale of Vietnam. PLoS One. 2018 Mar 1;13(3):e0193246. doi: 10.1371/journal.pone.0193246. ecollection 2018. 11
Diversity of infectious diseases in Vietnam Blood-borne infectious disease HIV 0.2-0.8% (rural to urban) High risk groups Injection drug users Commercial sex workers (male and female) C1 17.7% Prevalence of HBV Genotype I1 1.8% B2 0.9% HBV 10-20% HBsAg 40-80% HBcAg High prevalence in adult High prevalence to liver diseases National HBV Vaccination program Prevalence of HCV Genotype B4 79.6% Others 2.00% HCV 2.0-2.99% Dominance of Genotype G6 and G1 High prevalence to live diseases (hepatocarcinogen) G6 35.80% G3 1.80% G2 0.40% G1 60.00% 12
Diversity of infectious diseases in Vietnam Emergence of bacterial resistance Percentage of resistance of tuberculosis bacteria (1) 100% Antimicrobial resistance of colonized bacteria on Intensive Care Unit admission (2) 50.0% 40.0% 30.0% 28.2% 28.2% 50% 20.0% 10.0% 4.9% 2.9% 4.5% 0% 0.0% Ceftazidime Ticarcillin-clavunate Levofloxacin Sulfameth/trimeth Amikacin Imipenem Colistin Reference (1) Hang NT., et al. Primary drug-resistant tuberculosis in Hanoi, Viet Nam: present status and risk factors. PLoS One. 2013 Aug 13;8(8):e71867. doi: 10.1371/journal.pone.0071867. ecollection 2013. (2) Thuy DB., et al. A one-year prospective study of colonization with antimicrobial-resistant organisms on admission to a Vietnamese intensive care unit. PLoS One. 2017 Sep 14;12(9):e0184847. doi: 10.1371/journal.pone.0184847. ecollection 2017. 13
Investigator networks and facilities NCGM Counterparts Hospital facilities Community-base clinical trial model 14
Investigator networks and facilities NCGM Counterparts Bach Mai Hospital Cho Ray Hospital NHTD HCMC Hospital of Tropical Diseases NCGM National Hospital of Pediatrics HCMC Medical & Pharm University Hanoi Lung Hospital National Lung Hospital 15
Investigator networks and facilities Hospital facilities Bach Mai Hospital 1900 beds 1,46 million out-patient visits/year 127,000 in-patient visits/year Credited Laboratory (ISO 15189:2007) National Hospital of Tropical and Infectious Diseases Specialized in tropical and infectious disease (i.e. infectious diseases, HIV, HCV, liver diseases) 1300 beds (300 beds in Facility 1 and 1000 beds in Facility 2) Credited Laboratory ISO 15189:2007 and ISO9001:2008 National Hospital of Pediatrics 1,400 beds 1 millions out-patient visits/year 90,000 in-patient visits/year 18,000 surgeries/years Credited laboratory (hematology and chemistry) ISO15189:2007 16
Investigator networks and facilities Community-based clinical trials model National Institute (NIHE, Pasteur Institute, NIMPE) Suitability of the model Strength of the model District health center 1 or hospital 1 Provincial Hospitals or Health Centers District health center 2 or hospital 2 District health center 3 or hospital 3 Community-based studies (vaccine study, i.e. dengue, flu or infectious diseases in remote areas) Support to satellite sites for human resource, knowledge, techniques etc. Strengthen the regulatory and success of the patient recruitment study (under management of national level) NIHE: National Institutes of Hygiene and Epidemiology NIMPE: National Institute of Mariology, Parasitology, and Entomology 17
Regulatory and management system Start-up timeline Clinical trial environment in Vietnam 18
Regulatory and management system Start-up timeline Sequencing process Actual timeline: min 210 days Clinical Trial application MOH IEC submission Local IRB submission Protocol, ICF, overview of IB in Vietnamese Other documents in English Drug label: Use only for clinical trials Import/export license 30 calendar days 45-90 calendar days 60-90 calendar days 15-45 calendar days 19
Clinical trial environment in Viet Nam Business license or legal entity MOH (IEC) GCP Training Inspection Registered to MOH IRB Sponsor CROs Sites SMOs Med Plus 1 20
Reasons to land clinical trials in Vietnam Advantage Wide range of diseases and potential patient pool Adequate facilities (central) Qualified staff (medical license; GCP Certificate for Central Hospitals and Institutes) Experience (National Hospitals and Institutes) Cost saving and low competitors Improvement Timeline start-up Clinical trial experience of provincial or district health care centers Facilities of district hospitals in remote areas 21
ありがとうございます Cảm ơn 22