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The HIV
Netherlands Australia Thailand
Research Collaboration
Thai Red Cross AIDS Research Centre
|
HIV-NAT
Starting
Year: 1996
Main Topic Area:
Antiretroviral therapy and HIV care
Other Topic Areas:
Access to drugs, Virology, immunology, and laboratory
practices |
|
Implementers |
| The project was
implemented by the AIDS Research Centre of the Thai
Red Cross Society (TRCARC); the Netherlands National
AIDS Therapy Evaluation Centre (NATEC): Australian
National Centre in HIV Epidemiology and Clinical
Research (NCHECR). |
|
Funding |
Starting expenses, core infrastructure (office and
laboratory), and salaries of some research staff
members were funded by TRCS, NATEC, and NCHECR.
Expenses for the studies performed (including the
majority of research staff salaries, research drugs,
and laboratory assays) and presentation of the results
at meeting were funded by the sponsors of the studies,
ranging from pharmaceutical companies to the AIDS
Division of the Thai Ministry of Public Health (MOPH)
and the US National Institutes of Health (NIH).
Additional training of Netherlands-Australia-Thailand
HIV Research Collaboration (HIV-NAT) staff was funded
by NCHECR, NATEC, and sponsors of the studies. Funding
for training of others by HIV-NAT staff was provided
by HIV-NAT, the party requesting the training, and/or
a sponsor (e.g., the World Health Organization, Thai
MOPH, or a pharmaceutical company) |
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Objectives
|
|
Primary
objectives:
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To establish a
multi-centre HIV clinical research organization in
Thailand that functions according to
internationally accepted Good Clinical and
Laboratory guidelines
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To conduct clinical
intervention studies (and potentially vaccine
studies) that will yield answers to locally and
regionally relevant research questions
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To convince international
pharmaceutical companies and other potential
sponsors that scientifically and ethically sound
HIV clinical studies can be conducted in Thailand,
and that they should invest in such research in
Thailand
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To make drugs available
to study participants
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To strengthen the HIV
research infrastructure and regular HIV care
infrastructure
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To provide health care
workers with valuable experience with newly
available treatments.
|
The
secondary objectives
To serve as a training centre in the practical,
ethical, and scientific aspects of HIV care, and in
particular of HIV clinical trials, for staff from
government and university hospitals and other related
organizations in Thailand and the region. |
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Main
Activities |
At least six clinical studies have been successfully
completed and another five are currently ongoing at
three sites in Bangkok, providing up to 1000
HIV-positive individuals with effective treatment.
Validated quality-of-life research has been an
integrated part of one protocol and will be expanded
in future studies.
Results of studies are shared with local HIV-treating
physicians and Thai policy-makers and are presented at
international meetings.
HIV-NAT staff have taught at least 6 courses
concerning the conduct of HIV clinical research and
principles of Good Clinical and Laboratory Practice,
twice at the invitation of the AIDS Division of the
MOPH.
HIV-NAT has organized two national and two regional
meetings for health care workers who have limited
access to international journals, information
technology, and international meetings. Sponsorship
was found, enabling these health care workers to
travel to the meetings, which had well-known
international speakers in the field of HIV care and
research.
Ongoing and planned studies and the quality of the
research are reviewed yearly by an International
Advisory Board with 10 expert members. Interim
analysis safety and efficacy results of studies are
reviewed by an Independent Data and Safety Monitoring
Board of three members. All HIV-NAT staff take part in
educational activities, often supported by speakers
from NATEC or NCHECR with a particular skill. |
|
Outcomes/outputs |
Few objective measures are available yet. However,
since the first completed study (and the positive
feedback received from the United States auditors sent
by the sponsor of that study), starting new studies
and finding sponsors for proposed studies has been
easier; HIV-NAT is now actually actively pursued by
potential sponsors as a clinical trial site.
Study-related income enabled HIV-NAT to provide the
involved laboratories with some needed infrastructure.
Visits from NATEC and NCHECR staff and sponsor audit
teams have improved study and laboratory conduct,
which have benefited HIV-NAT's educational activities.
As well, study results and advice from the
International Advisory Board are heard and taken
seriously by local policy-makers.
Informal evaluation forms, completed by participants
attending the educational meetings, clearly indicate
that the educational activities meet an important need
felt by health care workers in the country and region.
Financially, the organization is nearly
self-supporting through its study-generated income,
and it needs to rely less and less on overseas skills
and intellectual support.
For the first three protocols, HIV-NAT was unable to
guarantee follow-up medication to participants upon
initiation of the study. However, it was able to enrol
all interested participants in follow-up protocols
after the sponsors' confidence grew and enthusiasm for
the activities increased. For the most recent study,
it was able to obtain long-term drug-availability
guarantees, either directly from the sponsor or
through a reduced pricing scheme |
|
Lessons Learnedd |
The major lesson learned from the experience of this
project is that, properly planned and executed, such
international cooperation on HIV/AIDS clinical
practices can have valuable benefits for local
populations and medical service providers. Among the
specific lessons learned:
Clinical trials can be conducted in Thailand according
to Good Clinical and Laboratory Practice (GCLP)
guidelines and should be feasible in other settings
outside the Western world. However, not all parties
involved in clinical research outside the Western
world may work according to these standards. The
majority of potential sponsor will demand that this
standard be implemented. Therefore non-Western
research organizations must have the resources
(especially time) and the willingness to support and
facilitate close collaboration with local
institutional ethical committees, hospital
laboratories, and local pharmaceutical companies in
pursuing GCLP.
A clinical trial is labour-intensive: adequate
personnel, willing to learn new skills, have to be
available at a site if a trial is to succeed. It was
learned that without dedicated staff and a responsible
coordinator at every individual research site, success
is impossible. Setting up a single site and expanding
the research activities to three sites in the course
of two years has been successful. "Long-distance
expansion" based on theoretical knowledge,
without an initial physical presence by the HIV-NAT
team, seemed not to work, given the multidisciplinary
nature of clinical trials and the fact that for most
staff the trial is only one of many duties.
Clinical trials do create access to drugs, but only
for a limited number of people. Drug access may
therefore not be an appropriate primary goal for
becoming involved in research.
Although economic difficulties are the main reason,
limited access to anti-HIV drugs in Thailand is also
due to a relatively slow registration process of newly
available anti-HIV agents and a rather passive
attitude on the part of some local pharmaceutical
representatives. HIV-NAT's experiences is that if
clinical studies are initiated in collaboration with
the companies' headquarters, the local subsidiaries
are forced into a pro-active import approach. As well,
valuable local experience is gained and local data are
generated that help the pharmaceutical companies
facilitate the registration of the agents.
Simply establishing a programme, doing the studies,
and generating useful data seem to exert pressure on
government agencies, local pharmaceutical company
representatives, and ethical committees to re-evaluate
their tasks and performance in the areas of HIV care,
clinical research, and importation and provision of
drugs. |
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Organization
Structure
and staffs
|
| Directors |
|
Prof.
Praphan Phanuphak,
MD, Ph. D., TRC-ARC and Faculty of Medicine,
Chulalongkorn University, Bangkok, Thailand
Prof.
David Cooper, MD, Ph. D., NCHECR,
Sydney, Australia
Prof.
Joep Lange, MD, Ph.D., IATEC,
Amsterdam, Netherlands |
| Deputy
Director |
|
|
A.
Prof. Kiat Ruxrungtham, MD, MSc. Faculty of
Medicine, Chulalongkorn University, Bangkok, Thailand
|
| HIV-NAT
Staffs : Full time Employed by HIV-NAT, NATEC or
NCHECR |
|
Dr
Chris Duncombe (Australia)
Senior Trial Physician/Clinical Trials Co-ordinator
Dr
Chaiwat Ungsedhaphand (Thailand)
Physician/Clinical Trials Co-ordinator
Dr
Peter Cardiello (USA), Physician/Clinical
Trials Co-ordinator
Dr
Mark Boyd (Australia) Physician/Clinical
Trials Co-ordinator
Dr.
Jintanat Ananworanich (Thailand),
Physician/Clinical Trials Co-ordinator
Ms
Techinee Chuenyam Manager and Co-ordinating
Clinical Trials Nurse
Ms.
Metta Tongtalung Clinical Trials Nurse
Ms.
Suchada Manotaya Clinical Trials Nurse
Ms.
Tarika Monhaphol Clinical Trials Nurse
Mr
Chowalit Phadungphon Data Manager
Ms
Jeerakan Janhom Secretary
Ms
Gunyanee Sattong Assistant Nurse
Ms
Sasiwimol Ubolyam Laboratory Mananger
Mr
Apicha Mahanotharit Medical Technologist
Mr
Theeradej Boonmangum Laboratory Technician |
| Part-time
HIV-NAT staffs: Employed by the Thai Red Cross
Society and/or the Faculty of Medicine,
Chulalongkorn University and/or HIV-NAT |
|
|
Dr
Mana Khongphattanayothin Data
Analyst/Statistician HIV-NAT Staff
John Liddy, Research Associate
Sunee Sirivichayakul
Medical Technologist
Somboon Nookhai Medical
Technologist
Supranee Buranapraditkul
Medical Technologist
Somsong Teeratakulpisarn
Clinical Trials Nurse
Dr Jettanong Klawsongkram
Clinical Trials Physician
|
| Contact
Information |
HIV-NAT, Thai
Red Cross AIDS Research Centre
Tel: 66-2-256-4638
FAX: 66-2-2547574
- Postal address
104 Rajdrumri Rd.,
Bangkok 10330 THAILAND
-
Electronic mail
General Information: chris.d@chula.ac.th
Webmaster:
rkiat@yahoo.com
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| ©
2001 HIV-NAT. All rights reserved |
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