Call to strengthen clinical research trial management in South-East Asia

Shobha Shukla and Bobby Ramakant, CNS
RIHES Laboratory, CMU
Since South-East Asian nations share a significant burden of major health challenges, it is important to strengthen clinical research management processes in these nations so that they can find relevant health solutions in their local contexts and ground realities. Thailand is undoubtedly an exception in South-East Asia with robust clinical research trials happening there since the past many years. But a lot remains to be desired in terms of clinical trial management capacity in countries such as Laos, Cambodia, Viet Nam, Myanmar, Indonesia, and Philippines, among others.

One example of a Thai research site, which not only has demonstrated an impressive track record of successfully conducting over 35 clinical research trials in the past years but also has been globally acknowledged for excellence in community involvement, recruitment and high retention of study participants, is Research Institute for Health Sciences (RIHES), Chiang Mai University. RIHES has collaborated with global leaders in health research such as National Institutes of Health (NIH), USA; Contraceptive Research and Development Programme (CONRAD); Microbicides Trial Network (MTN); HIV Prevention Trial Network (HPTN); HIV Vaccine Trial Network (HVTN); World Health Organization (WHO); among others.

Dr Suwat Chariyalertsak, Director of RIHES and key researcher at this site for a long list of HIV prevention and treatment trials, said to Citizen News Service (CNS) that, "Since we have lot of experience in clinical trial management, we opened a course on clinical trial management last year. So doctors, nurses, researchers from other medical schools and hospitals can come and see how we manage the clinical trial sites. It is good for our country if we have more medical schools with good clinical trial units, so in future it will be more easy to have a network of good research sites. Right now we have two sites, one here in Chiang Mai and the other in Thai Red Cross in Bangkok."
Dr Suwat Chariyalertsak, RIHES

Added Dr Suwat: "We are also thinking to open this training programme for participants of other countries of South East Asia as they also need to strengthen clinical trial capacity in their countries. If you look in this Asian region, India, Japan, South Korea and Singapore have very strong clinical trial management capacity followed by Thailand. But countries such as Indonesia, Viet Nam, Cambodia, Laos, Myanmar, Philippines, etc have very limited clinical research trial management capacity right now. They need to strengthen their basic infrastructure as well as competencies of clinical investigators’ team, and also need some support or sponsors. WHO in this region is interested in building the capacity of other member countries such as Indonesia, Myanmar, etc in clinical trial management. It is good for these countries too because they too are  dealing with major health challenges. So it will be most appropriate for their doctors and other clinical researchers to be involved with these clinical research trials. We are thinking of engaging these countries of the region from next year for training. We will inform our colleagues in this region and if they are interested they can join."

RIHES has its main administrative and clinical research management office in the medical campus of Chiang Mai University (CMU) which also has a 1800 bedded hospital attached to a prestigious medical college. This RIHES campus also houses very well-equipped bio-safety level II and III laboratories to help strengthen diagnostic capacities and complement health research.

RIHES started about 40 years back to help respond to major health crises back then: anaemia and malnutrition in children. Those children who survived malnutrition and recovered to health 30-40 years back, are still being followed by RIHES. So undoubtedly RIHES has a very long cohort, said Dr Suwat.

Vitamin A deficiency was another major problem addressed by RIHES. Night blindness is one of the complications due to Vitamin A deficiency but now it is very rare limited only to very remote areas where access to healthcare services is very sparse.

RIHES has two more buildings in the main CMU campus near the mountains, one of which manages activities such as surveys, programmes in villages on substance abuse, injecting drug use, alcohol consumption, etc. "We also have some nutrition projects, environmental science research, pesticide contamination, air pollution, etc" said Dr Suwat.

RIHES has four sub-units: Centre for Substance Abuse Research, Centre for Molecular and Cell Biology for Infectious Diseases, Centre for AIDS and STIs, and Centre for Applied Health Science Research.

Major clinical research trials that are currently going on at RIHES include: MTN017 (a phase-II extended safety rectal microbicide study with MSM and transgender participants), IMPAACT, iPrex, among others. [Read CNS update on MTN017 from June 2014 here]

IMPAACT (International Maternal Paediatric Adolescent AIDS Clinical Trials Network) is aiming to significantly decrease incident HIV and HIV-associated infections and to decrease mortality and morbidity due to HIV and HIV-associated infections and co-morbidities among infants, children, adolescents and pregnant/postpartum women.
Another major hallmark for RIHES is the setting up of PIMAN clinic (Prevention of Infection in Man). PIMAN also has a Thai meaning “heaven or paradise”. Not only PIMAN clinic does not even remotely look like a clinic or any healthcare facility but also it is located outside the hospital campus near one of the most happening streets in Chiang Mai. "Prevention research trials often involve healthy MSM and transgender people who may not like to come to a hospital; rather they  may feel more comfortable to come to PIMAN." said Dr Suwat.

Data Management Unit is also very well established at RIHES.

Two Community Advisory Boards (CABs) function at RIHES-- one for HIV prevention research and the other for HIV treatment research. [Read latest update from CNS about CABs in RIHES here]

Dr Suwat informed that the CAB also publishes a newsletter in Thai language once every 2 months. 4000 copies of every newsletter are printed and distributed in 5 provinces around Chiang Mai at the village and sub-district level. He said that, "This newsletter is in Thai language and gives information about HIV research updates from not just our RIHES site but from around the world, interviews of CAB members, among other things. We publish regular updates on clinical trials to keep recipients up to date on information, especially the high risk groups. Likewise we published information around MTN017 to advertise and to inform people, and when  men who have sex with men (MSMs) and transgender read it, they contacted us for further information. Sometimes we also disseminate small posters with the newsletter for the recipients to exhibit at clinics or hospitals in their community. When our staff at RIHES visits regional or global HIV science events we request them to write an update in a simple manner in Thai language and include it in our CAB newsletter.”

Dr Suwat said that, "Good quality specimens are sent from other hospitals and clinics to our laboratory at RIHES which is very well equipped. There are some tests that can be done at the clinics itself such as HIV rapid test. If we can do tests here in our laboratories we do it here, but when absolutely necessary then only we send samples to laboratories in the US, and sometimes in India."

Dr Kittipong Rungruengthanakit, Laboratory Director and Deputy Director of RIHES said to CNS: "Some specimens might be tested onsite but some specimens need to be shifted to the laboratories to be tested centrally. One of the key issues is that the quality of the specimen has to be really high, and should not be compromised at any stage-- from the time it is collected until it reaches the testing laboratory."

Dr Kittipong added: "Specimen collection (plasma, serum, etc) is in a vial or tube as per the requirement of the testing laboratory. These units are responsible for managing the specimens and also for storage in deep freezers in liquid nitrogen, and then we make the shipment to the testing laboratory as per the study protocol. To do the shipment we have to deal with the regulatory issues such as import and export permits. We have to comply with the dangerous good regulations for biological hazards. We have to pack them in  proper containers, and abide by other regulatory safety measures according to the guidelines of International Air Transport Association (IATA). Sometimes we need to test the samples without delay for the safety of the study participant, and we also  maintain a cohort for future testing."

Strengthening clinical or health research trial management capacities across the South East Asian region will perhaps help find relevant solutions for local challenges that key populations face. Let us hope that as XX International AIDS Conference opens on the theme of "Stepping Up The Pace" next month, strengthening clinical research trial management in the low- and middle- income countries remains as one of the priorities.

Also read:

Shobha Shukla and Bobby Ramakant
Citizen News Service - CNS
9 June 2014