KUALA LUMPUR, March 27 — The Ministry of Health (MOH) has imposed a moratorium on the setting up of new clinical research centres (CRCs) under the Institute for Clinical Research (ICR).
Health deputy director-general (research and technical support) Dr Nor Fariza Ngah said there are currently 37 CRCs nationwide under the ICR – the clinical research arm of the MOH – and that the operation of CRCs requires “financial and human resources that compete with the operation of existing clinical services”.
“In line with that, a moratorium on the formation of CRCs throughout Malaysia is an appropriate measure to face such constraints,” Dr Nor Fariza said in a circular dated last March 21, as sighted by CodeBlue.
“Therefore, no new CRCs will be set up until a point in time when financial and human resource constraints can be managed. However, the operation of existing CRCs will continue to be supported and run as usual.”
The current CRCs under the ICR – which is one of the institutes under the National Institutes of Health (NIH) – are based in MOH hospitals throughout each state in the country in the central, north, south, and east zones, as well as in Sabah and Sarawak.
This moratorium on new CRCs is the MOH’s latest move to deal with a severe shortage of health care professionals in the public health service, including doctors across levels and nurses.
The MOH has diverted all nurses from specialist clinics to wards in its hospitals nationwide, except those in O&G and paediatrics; excluded district hospitals from the first intake of housemen placements this year; and instituted the rotation of medical officers from various departments, including non-clinical units, to the Green Zone (non-critical cases) of emergency departments across all its hospitals.
CRC Moratorium Risks Cutting FDI, Skilled Jobs in Life Sciences, Knowledge Transfer
The Galen Centre for Health and Social Policy said the CRC moratorium could affect Malaysia’s ability to offer sites and capacity for clinical trials by pharmaceutical companies, particularly those that bring in hundreds of millions of ringgit in foreign investment, skilled employment opportunities in the life sciences, and valuable clinical and scientific expertise.
“A moratorium may result in Malaysia being limited to the current research capacity and unable to take advantage of new and innovative opportunities in the future,” Galen Centre chief executive Azrul Mohd Khalib told CodeBlue when contacted.
Malaysia – which currently ranks third (behind Singapore and Thailand) in Southeast Asia on clinical trials – surpassed RM1 billion in cumulative clinical research contract value to gross national income from 2012 to 2023. Over the last decade, over 2,000 sponsored and approved research studies have been conducted in Malaysia.
Azrul explained that Malaysia is currently a country of choice for clinical trials due to an adequate and efficient health care system, highly qualified medical professionals, and an English-speaking and multiethnic population.
“The latter, in particular, is a particular advantage in early-stage clinical trials which allows for genome variations to be observed for any treatment,” Azrul said.
Early-stage, covering Phase 1 and 2 of clinical trials, are usually small-scale and limited to small cohorts of patients, with the intention of finding out the safety of a new treatment and its side effects.
“They are the foundation of a successful clinical trial which may exceed billions in investments. The moratorium, particularly if it affects the research workforce, could affect Malaysia’s ability to take advantage of new opportunities to be involved in such trials.
“Other countries such as Indonesia, Thailand, and Singapore will be more than willing and able to step into the void left by Malaysia.”
When asked if it was a prudent decision by the MOH to sacrifice clinical research to maintain clinical services due to staff shortages, Azrul said maintaining clinical services was an immediate short-term need, whereas clinical research is a long-term investment with implications for years to come.
“Foreign and local doctors and nurses can be hired to fill the gap in human resources needs in clinical services, but clinical research capacity, and international reputation for dependency and consistency take decades to build and sustain,” he said.
“It would be short-sighted and a mistake to diminish our clinical research capacity in favour of strengthening clinical services. Some people are good at treating patients, others are better at research.”
Azrul listed benefits of Malaysia’s involvement in clinical research opportunities, especially international ones:
- As a country involved in clinical trials for innovative and groundbreaking therapies and drugs, Malaysia could negotiate for preferential pricing when those drugs go onto the market;
- Job opportunities in specialised clinical research areas could become available, allowing for knowledge transfer and increase in local expertise;
- There will be investment in building key research infrastructure that could be utilised beyond the lifetime of the clinical trial that built them.
“Further opportunities for clinical research could open up after the initial work has been completed. With a moratorium in place, these opportunities could sail past Malaysia in favour of our neighbours such as Indonesia, Thailand, and Singapore,” said the Galen Centre.
More CRCs Needed to Study Certain Populations in Different Districts
A medical doctor in the public health service with some research experience claimed that clinical researchers in CRCs were recently told to prepare for possible rotation to the Green Zones of emergency departments.
The doctor questioned how they would hit their target of clinical research papers and many research projects, if their CRC colleagues were required to be on duty in the emergency department on a rotational basis.
“My junior colleagues in CRC are tired and they intend to leave. If MOH wants to pull out doctors from CRC, it shows the declining importance of CRC,” the doctor told CodeBlue on condition of anonymity.
The doctor explained that even though there are existing CRCs in each state, clinical researchers who want to do research in certain towns or districts without CRCs have to travel to those places from the CRC they’re based in, adding to their work burden. “When I was in an outskirt area, I was told that there is no CRC here and any referral is to a CRC nearby”.
“Sometimes, there are certain types of diseases in a certain area. For example, seaside areas tend to have more hypertensive and high cholesterol cases because they tend to eat a lot of salted food. Places in Kelantan and Terengganu tend to have more diabetes cases because people there put sugar in everything, sometimes even in clean water.”
Clinical research isn’t just limited to trials for new drugs, but covers a large area in medicine, including medical devices, a new method of clinical management for patients, examining existing clinical services, or even a new form of method to assist in improving health services. “So if we sacrifice that in view of services, how will services ever improve?”.
Clinical research is also used for government policy that extends beyond the MOH, the doctor said, citing research conducted in CRCs that played a role in public policies, especially during the Covid-19 pandemic.
“If not for our CRC colleagues, many of the Covid protocols from research done wouldn’t have materialised. To them, I say thank you and to the Ministry – please do not reduce their importance,” said the doctor.
“I have colleagues who constantly complain about not having a career in the field, yet they are ever ready to help us – sometimes even beyond working hours.”
