regional manager department of international trials · hiv- positive with tb is around 8.8% •...
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Nattha Kerdsakundee,Ph.D.Regional Manager
Department of International Trials
© 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 registered
trademarks of the National Center for Global Health and Medicine.
© 2018 National Center for Global Health and Medicine 3
Locate in the center of Southeast Asia with
area around 513,115 sq.km
Top 10 Tourist Attraction Countries in the
World in 2018
Climate:
Tropical and high humidity
3 seasons (only 2 in south)
Hot: March-June
Rainy: July-October
Cool: November-February
Temperature around 19-38°C
https://www.drivingdirectionsandmaps.com/thailand-google-map/
© 2018 National Center for Global Health and Medicine 4
Population: 68.4 M Crude Birth rate 10.7 (per 1000)
Crude Death rate 8.3 (per 1000)
Total Fertility rate 1.58
Life expectancy: 75 year
Transition into aged society (age>60 year: 17% of population; 2018 est)
Source: Institute for Population and Social Research
Capital city: Bangkok
77 provinces
Major language: Thai
Major religion: Buddhism
GDP Per Capita: 6,992 USD (2018 est)
GDP growth rate: 3.87% (2018 est)
Health expenditure approx. 4.1% of GDP
(241 USD per capita)
(Source: ceicdata)
© 2018 National Center for Global Health and Medicine 5
Health status in Thailand
Source: WHO
• The Non-communicable diseases are the major cause of
death.
The prevalence of NCD is also on the rise due to
• changing lifestyles: smokers, high in meat, salt, fat, and
sugar content meal
• Aged society, the increasing of developing respiratory
diseases, cancer, and diabetes
• Infectious diseases remain an issue of Thailand due to its
tropical climate.
- Nearly 450,000 people in Thailand are living with HIV/AIDS,
but the number of new HIV cases per year decreased
- Dengue fever affects tens of thousands annually
- Other infectious diseases including influenza, tuberculosis,
and malaria
© 2018 National Center for Global Health and Medicine 6
Infectious diseases in ThailandDengue Fever
0
20000
40000
60000
80000
100000
120000
140000
160000
180000
2012 2013 2014 2015 2016 2017
No.
of p
atie
nts
Dengue 2012-2017
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Source: Bureau of Vector-borne Disease, Department of disease control, Thailand,Polwiang, Sittisede Travel Medicine and Infectious Disease , Volume 14 , Issue 4 , 398 - 406
In 2018, the updated no. of Dengue cases are 25,408 case and Death 33 case
In 2013, Thailand experience the largest dengue epidemic in more than two decades
2018 est.
2017
© 2018 National Center for Global Health and Medicine
0
5000
10000
15000
20000
25000
30000
35000
40000
2012 2013 2014 2015 2016 2017
No.
of P
atie
nts
Malaria 2012-2017
7
Malaria
Infectious diseases in Thailand
- P. vivax 58% - P. Falciparum 41%- P. Malariae 0.1%- mixed Pv and Pf 0.7%
Source: Bureau of Vector-borne Disease, Department of disease control, Thailand
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
© 2018 National Center for Global Health and Medicine 8
Infectious diseases in Thailand
0
10000
20000
30000
40000
50000
60000
70000
80000
2012 2013 2014 2015 2016 2017
No.
ofr
egis
tere
d pa
tient
s
Tuberculosis 2012-2017Tuberculosis
• HIV- positive with TB is around 8.8%
• 2.2% of new cases with MDR/RR-TB
• 24% of previously treated cases with MDR/RR-TB Source: WHO Global TB report 2017
Source: Bureau of Tuberculosis Department of disease control, Thailand
© 2018 National Center for Global Health and Medicine 9
Rabies outbreak, 2018
• Rabies has once again raised its head in Thailand, killing many people in the country since last year.
• 8 people died in 2018
• 359 confirmed animals of rabies
© 2018 National Center for Global Health and Medicine 10
Antimicrobial resistance in Thailand
Imipenem resistance
TIER I- areas with credible evidence of artemisinin
TIER II- areas with significant inflows of mobile &
migrant populations from tier I areas or shared
borders with tier I areas
TIER III- endemic areas without evidence of
artemisinin resistance and have limited contact with
tier I areas
Distribution of MDR-TB Cases, Thailand
Distribution of Artemisinin Resistance
© 2018 National Center for Global Health and Medicine 11
Healthcare systems
Source: Thailand Health profile 2008-2010
National Health Security Systems (public hospital only)
Source: OECD Health Statistics 2016: WHO Global Health Expenditure Database
Health Expenditure in Thailand 2014Out of pocket
Other Private
Public
85%
12%3%
© 2018 National Center for Global Health and Medicine
Source: PwC Health Industries Leader
Thai government and tourismAuthority of Thailand havepromoted medical and healthtourism policy
Healthcare market trend
Source: GlobalData
12
Source: EIC SCB, World Health Organization, BMI
© 2018 National Center for Global Health and Medicine
- National Vaccine Institute, MOPH
- Government Pharmaceutical Organization (GPO)- Produce over six million doses a year (diphtheria, pertussis, tetanus and encephalitis)
- Joined with Sanofi Aventis to produce more than 20 million vaccine dose (encephalitis,
hepatitis B, rabies and influenza
- Center of Vaccine development, Mahidol University
- Chula Drug Discovery and Development Research Center
- Excellent Center for Drug Discovery, Mahidol University
Research and development
Vaccine
Phase I
Phase II
Phase III
Phase IV
14
Clinical research in Thailand
Drug discovery
IND
subm
itted
FDA
appr
oval
- Dengue- HIV- Influenza- JE- Chikungunya- Hepatitis
Natural compou
nd
Pre-Clinical Phase
© 2018 National Center for Global Health and Medicine
Pre-Clinical Phase
Phase I
Phase II
Phase III
Phase IV
15
Clinical research in Thailand
Drug discovery
IND
subm
itted
FDA
appr
oval
Pre-Clinical Phase
In vivo (animal) testing
- National Laboratory Animal Center, Mahidol University
- Center for Animal Research, Naresuan University
- National Primate Research Center of Thailand,
Chulalongkorn University
© 2018 National Center for Global Health and Medicine
1
4
4
12
78
54
92
185
412
356
2
13
21
73
374
381
890
1,050
2,029
2,328
0 500 1000 1500 2000 2500
Brunei
Lao
Myanmar
Cambodia
Vietnam
Indonesia
Philippines
Malaysia
Singapore
Thailand
Total trial
Active recruiting trial
16
Phase I
Phase II
Phase III
Phase IV
Drug discovery
Pre-Clinical Phase
IND
subm
itted
FDA
appr
oval
Clinical research in Thailand
Source: NIH U.S. National Library of Medicine, ClinicalTrials.govNumber of Clinical Trials
© 2018 National Center for Global Health and Medicine
Clinical trials in Thailand covers a broad
range of disease profiles including non-
communicable and communicable
disease.
121
335
386
388
827
0 100 200 300 400 500 600 700 800 900
I
IV
N/A
II
III
Trial Phase
17
Clinical research in Thailand
Number of Clinical Trials
Thailand has an ability to conduct all phase of
clinical trial
Most of Clinical trials are in Phase III
Source: NIH U.S. National Library of Medicine, ClinicalTrials.gov
39
45
46
52
61
63
66
69
80
84
103
274
0 50 100 150 200 250 300
Asthma
Malaria
Pain (postoperative)
Influenza
Anemia
Hepatitis B
GI neoplasm
Breast neoplasm
Lung Non-small cell
Diabetic type 2
Respiratory infection
HIV
Disease Type
Number of Clinical Trials
© 2018 National Center for Global Health and Medicine 18
Clinical research in Thailand
Source: Deloitte
Attracting factors
• Large treatment-naïve patient
population
• Highly skilled workforce
• Broad range of disease profiles,
including tropical diseases
Biggest impediment
• The lengthened of the
independent ethical approval
process and the import license
approval process
© 2018 National Center for Global Health and Medicine 19
How to start clinical trial
Picture from rahlat.com
© 2018 National Center for Global Health and Medicine 20
Regulator of Drug and Medical DeviceThai FDA organization structure
Ministry of Public Health
Food and Drug Administration Secretary-General
National Food Safety Committee
National Drug Policy Committee
National Coordinating Committee on Chemicals
ManagementHazardous Substances Committee
Narcotic Control Committee
Committee on Prevention against Abuse
of Volatile Substances
Psychotropic Substances Committee
Medical Device Committee
Cosmetic Committee
Drug Committee
Food Committee
Food and Drug Legal Group
Narcotic Revolving Fund
One Stop Service Center
Information Center
Complaint & Suppression Center
Anti-corruption Center
Internal Audit Group
Public Sector Development Group
Deputy Secretaries – General (3)
Senior Experts
Bureau of Cosmetic and Hazardous Substances
Bureau of Import and Export Inspection
Bureau of Drug
Bureau of Food
Narcotics Control Division
Medical Devices Control Division
Cosmetic Control Group
Hazardous Substances Control Group
Office of the Secretary
Technical Planning Division
Public &Consumer Affairs Division
Rural and Local Consumer Health Product Protection and Promotion Division
© 2018 National Center for Global Health and Medicine 21
Clinical Trial process
• Sequential process
• Parallel process
© 2018 National Center for Global Health and Medicine 22
Clinical Trial process
• Sequential process
InspectionCompliance with •GCP •Protocol•Regulations
© 2018 National Center for Global Health and Medicine 23
Clinical Trial process
• Parallel process
© 2018 National Center for Global Health and Medicine 24
Hospitals conducting Clinical Trials
• Every hospital can conduct clinical trials depending on facility, infrastructure and staff.
• Most of clinical trials have been conducted in University hospital and Specialized hospital.
• More than 100 public hospital provide specialized medical services
Bangkok
Province
District
Sub-district
Regional hospitals (33)
Central Hospital and others including
specialized hospital (55)
Community hospitals
(723)
Health center (9,768)
Municipality Medical Center
Private Clinic
(17,671)
Pharmacy(11,154)
University Hospital (20)- Bangkok (8)- Northern (3)- Northeast (4)
- Eastern (1)- Southern (4)
Private hospital
(321)
General hospitals (83)
Other public
hospitals (120)
© 2018 National Center for Global Health and Medicine 25
20 IRB/IEC accredited by Thai FDA
© 2018 National Center for Global Health and Medicine 26
Examples of Current Clinical TrialsTopic Phase Disease No. of
participants
Site Sponsor
Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children
and Adolescents
I HIV infection
65 • Siriraj Hospital • National Institute of Allergy and Infectious Diseases (NIAID)
Phase II Study of AZD9291 in Advanced Stage NSCLC With EGFR and T790M Mutations Detected
in Plasma Ct-DNA (PLASMA)
II Carcinoma, Non-Small-Cell Lung
108 • Ramathibodi Hospital • National University Hospital, Singapore
• AstraZeneca
A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis
Vaccine in Healthy Infants
III Poliomyelitis
1,329 • Siriraj Hospital• Chiang Mai University
Hospital
• LG Chem
A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome
(MDS)
IV Myelodysplastic Syndromes
120 • King Chulalongkorn Memorial Hospital
• Rajavithi Hospital• Ramathibodi Hospital• Siriraj Hospital• Chiang Mai University
Hospital• Srinagarind Hospital• Khonkean Regional Hospital• Thammasart Chalermprakiert
Hospital• Naresaun University hospital• Sapprasitthiprasong Hospital
• Hoffmann-La Roche
© 2018 National Center for Global Health and Medicine 27
Notes!!
Leading conductor of clinical research in pharmaceuticals among all ASEAN
Highly skilled workforce (15,509 FTEs)
Well developed medical equipment
and facilities
High incidence of Tropical Disease
High cost-effective in hosting trials
Large patient population (111,672 participant in 761 trials)
© 2018 National Center for Global Health and Medicine 28Picture: https://www.spcthailand.com/
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