Huge potential: The economic value of the global clinical trial market stood at over RM368bil last year, with a projected growth of 6.5% annually. — 123rf
WHEN you think about industries with big potential for growth in Malaysia, chances are you will not immediately think about the clinical research industry.
However, as reported in May, the industry has brought in RM1.38bil in cumulative gross national income since 2012 for the country, with over 2,450 clinical trials conducted. And we stand to benefit further from the significant economic value of the global clinical trial market, which stood at over US$80bil (RM368bil) last year, with a projected growth of 6.5% annually.
It is no surprise then that Prime Minister Datuk Seri Anwar Ibrahim has expressed intentions to prioritise efforts to make the country a regional hub for clinical research.
As he pointed out, last year saw an encouraging growth in the industry in Malaysia with a 24% increase in global clinical trials compared with 2022.
Malaysia’s clinical research ambitions got a further boost in a July study on country readiness for global clinical trials, which put Malaysia at the top among South-East Asian countries.
The study, published by pharmaceutical data and testing solutions provider IQVIA, shows Malaysia also ranked 28th globally, with Indonesia being the only other South-East Asian country in the top 30. The top three countries were the United States, Germany, and Japan.
The rankings were based on country scores in three key metrics: patient availability, clinical infrastructure, and operating infrastructure, which are further split into sub-metrics.
This spotlight on the country’s conducive environment for clinical trials is good news for Malaysia, indicating that we are on the right track in expanding the industry.
Long time coming
Malaysia actually started focusing on expanding this industry slightly over a decade ago with the establishment of Clinical Research Malaysia (CRM) under the Health Ministry in 2012.
As a one-stop centre for clinical research support in the country, CRM has tried to make as conducive an environment as possible for clinical research to attract more investors and sponsors. In Malaysia, these global clinical trials are often multinational trials wholly sponsored by pharmaceutical organisations, biotech companies, and medical devices companies.
Back in 2015, CRM used Malaysia’s diverse population as one of our main selling points to potential investors of clinical research, but its chief executive officer, Dr Akhmal Yusof, says they have since had to switch their strategy with the evolving global demographic.
“That [a multiracial population] is the same value proposition in Australia, Singapore, and even in the United States now, so we have to create a new value proposition, and that is to deliver clinical research with speed, reliability, and quality.
“That’s why we need ease of business, people who are trained well, building professionalism,” Dr Akhmal says to Sunday Star.
One of the things CRM focused on was hastening the application and approval process by revamping it.
In 2012, the average time taken from when a sponsor expressed interest to the start of the clinical trial was about 350 days, almost a year.
CRM, along with the cooperation of relevant authorities, has since managed to reduce the application timeline to about three months.
Meanwhile, among the measures CRM has undertaken to increase the number of skilled workers ready to take on roles in clinical research, is establishing a Centre of Excellence – opened by Health Minister Datuk Seri Dr Dzulkefly Ahmad last month – to train young graduates in clinical research, says Dr Akhmal.
The government is also looking to venture more into early- phase first-in-human (FIH) trials, as currently, the majority of the clinical trials conducted in Malaysia are of the Phase II and III variety.
FIH trials are a type of clinical trial in which a new drug, procedure or treatment is tested in humans for the first time, after undergoing tests in laboratory and animal studies.
Phase II trials determine efficacy and further evaluate safety; Phase III confirms efficacy, monitors side effects, compares with standard or similar interventions, and collects information about safety, according to the US National Institutes of Health (see graphic, right).
Since the start of this year, the clinical research industry in Malaysia appears to have accelerated its growth in economic value.
“From 2022 going into 2023, the number was about RM133mil. The point I want to make is that up to June this year, we see an escalation number of RM210mil. This is not a number coming from one sector but coming from the Health Ministry, the private sector, and also academia,” says Dr Akhmal.
In January, Swiss healthcare giant Roche Pharmaceuticals picked Sarawak General Hospital as its global FIH clinical trial site, making Malaysia the seventh country included by Roche in the study and the first within the Asia-Pacific region.
Roche has invested around RM190mil in clinical trials in Malaysia since 2012.
Dr Dzulkefly launching the Centre of Excellence at the CRM last month, with Dr Akhmal (second from left) and Health director-general Dr Muhammad Radzi Abu Hassan (third from right) looking on. — Health Ministry
The path forward
While Malaysia has done a lot to improve the clinical research industry over the years, there is still more that can be done to realise its full potential.
Looking forward, CRM has come up with its next 10-year plan, setting several key performance indicators (KPI) as part of its 2033 goal.
Among the KPIs set were to hit a target of 80 Phase I trials, reach RM2.1bil in clinical research gross national income, create 4,000 skilled jobs in clinical research, and get 3,500 new sponsored research projects.
CRM acknowledges that more can be done to improve the ease of business and in offering more incentives such as tax breaks to lure more investors to the country.
Revolutionising the electronic medical record system in the country would also speed up operational processes such as screening for patients with suitable profiles for the requirements of clinical trials.
However, some of these things are beyond the scope of CRM’s authority.
Then there’s the issue of consistent manpower. Due to the high demand for skilled clinical research workers, a number of those trained through CRM programmes end up leaving for the private sector.
Meanwhile, in the IQVIA study, Malaysia’s highest score was in patient availability, which measured sub-metrics such as population, healthcare access and quality index, and number of physicians, among others.
But this may be undermined by the lack of knowledge among the populace about clinical trials.
For one, many misconceptions about the industry, such as the “guinea pig” myth, persist.
CRM says there is a need to raise more awareness as the misconception that clinical trial participants are being treated as guinea pigs still persists in Malaysia. — 123rf
No test bunny
Clinical investigator based at Hospital Kuala Lumpur, Dr Muthukkumaran Thiagarajan, who specialises in oncology, concedes that the misconception he faces the most often is those who think clinical trial participants are being treated like guinea pigs.
However, he says most patients are open to the suggestion of clinical trials once they understand more about how trials are run and the benefits they stand to gain from participating in such trials.
He wants to assure the public that most of the drugs or treatments being researched in Malaysia have been extensively tested before being used on patients.
“We know a lot more about their efficacy and toxicity. Therefore, we are better able to monitor the safety of patients involved in the trial,” he says.
Participating in trials also means patients, especially in oncology, who may have exhausted every other avenue for a cure, can have access to new drugs or treatments that may not be available to them otherwise.
“Because it’s cancer, it might not be able to cure them but patients who respond well to the new treatment can get an improved quality of life,” says Dr Akhmal, adding that CRM acknowledges there is a need to raise more awareness about the safety and benefits of clinical trials to make it easier to recruit patients or healthy participants for such trials.
Mohd Zulhilmi Paiz Ismadi, a haemophilia patient, who is participating in a clinical trial for the disease, shares that he is benefiting from the new treatment being tested.
“It is easier to administer, more convenient and I foresee better compliance,” he notes, explaining that his previous treatment took up to 45 minutes a day to administer at a frequency of twice a week.
For comparison, he only needs to undergo the new treatment, under the supervision of the trial investigating team, once every two months.
However, Dr Muthukkumaran says they usually struggle more with the huge number of patients unfit to participate in trials due to advanced disease or other underlying medical conditions.
This is Part 1 of Sunday Star’s report on Malaysia’s clinical research ambitions.
