Viet Nam: a potential researchsources forinfectious diseases · Viet Nam: a potential...

Viet Nam: a potential research sourcesfor infectious diseases

Tam Nguyen, Regional Manager

Department of International Trials

National Center of Global Health and Medicine

© 2018 National Center for Global Health and Medicine 2

Disclaimer

These Power Point slides are the intellectual property of NCGM under the copyright laws.Used by permission. All rights reserved. NCGM and the NCGM logo are registeredtrademarks of the National Center for Global Health and Medicine.

© 2018 National Center for Global Health and Medicine

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 VietnamWeather

• North: sub-tropical• South: tropical

Land areas

• 331,200 km2

Population

• 93,5 million (2015)• 305 people/km2

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 VietnamHealthcare system

• Ministry of Health (MOH)• MOH Departments• Research Institutes (NIHE, Pasteur Institutes, etc.)• Medical Colleges• National Hospitals (General and specialist)

Government

• Provincial Health Bureaus• Provincial Hospitals (General and Specialist)• Provincial Preventive Medical Center• Medical Secondary Schools

Province People Committee

• District Health CentersDistrict of People Committee

• Commune Health CentersCommune Prov. Committee

6


Introduction to VietnamHealthcare system

7.5%• Healthcare expenditure (%GDP) in 2017

86%• Social health insurance coverage in 2017

76.0• Years of life expectancy in 2018 (rank 56th 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


Diversity of infectious diseases in VietnamOral-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 VietnamAirborne - borne transmission distribution


10


Diversity of infectious diseases in VietnamVector - borne transmission distribution


11


Diversity of infectious diseases in VietnamBlood-borne infectious disease

HIV

• 0.2-0.8% (rural to urban)• High risk groups

• Injection drug users• Commercial sex workers (male and female)

HBV

• 10-20% HBsAg• 40-80% HBcAg• High prevalence in adult• High prevalence to liver diseases• National HBV Vaccination program

HCV

• 2.0-2.99%• Dominance of Genotype G6 and G1 • High prevalence to live diseases

(hepatocarcinogen)

B479.6%

C117.7%

I11.8%

B20.9%

Prevalence of HBVGenotype

G160.00%

G20.40%

G31.80%

G635.80%

Others2.00%

Prevalence of HCV Genotype

12


Diversity of infectious diseases in VietnamEmergence of bacterial resistance

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.

28.2%

4.9%

28.2%

2.9% 4.5%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

Percentage of resistance of tuberculosis bacteria (1)

0%

50%

100%

Antimicrobial resistance of colonized bacteria on Intensive Care Unit admission

(2)

Ceftazidime Ticarcillin-clavunate LevofloxacinSulfameth/trimeth Amikacin ImipenemColistin

13


Investigator networks and facilities

NCGM Counterparts

Hospital facilities

Community-base clinical trial model

14



NCGM

Bach Mai Hospital

NHTD

National Hospital

of Pediatrics

National Lung

HospitalHanoi Lung

Hospital

HCMC Medical &

Pharm University

HCMC Hospital

of Tropical Diseases

Cho Ray Hospital

NCGM Counterparts



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

Hospital facilities



National Institute (NIHE, Pasteur

Institute, NIMPE)

Provincial Hospitals or

Health Centers

District health center 1 or hospital 1



Community-based clinical trials model

Suitability of the model• Community-based

studies (vaccine study, i.e. dengue, flu or infectious diseases in remote areas)

Strength of the model• 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 EpidemiologyNIMPE: National Institute of Mariology, Parasitology, and Entomology



Start-up timeline

Clinical trial environment in Vietnam

18



Clinical Trial application

Local IRB submission•Protocol, ICF, overview of IB in Vietnamese

•Other documents in English•Drug label: ‘Use only for clinical trials’

MOH IEC submission

Import/export license

Start-up timeline

30 calendar days 45-90 calendar days 15-45 calendar days60-90 calendar days

Actual timeline: min 210 days

Sequencing process


Clinical trial environment in Viet Nam

CROs

SMOs

Sponsor

IRB

Sites

MOH(IEC)

Med Plus 1

Business license or legal entity

Registered to MOHGCP TrainingInspection

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

Viet Nam: a potential researchsources forinfectious diseases · Viet Nam: a potential...

Documents

Transcript of Viet Nam: a potential researchsources forinfectious diseases · Viet Nam: a potential...