Ready to go: The Sarawak General Hospital has been working hard to build the hospital’s capacity at its Phase I-equipped Clinical Research Centre. — Others
THE clinical research industry is a booming one, with a global value standing at over US$480bil (RM368bil) last year, and it is projected to grow 6.5% annually.
In Malaysia alone, it has brought in RM1.38bil in cumulative gross national income since 2012, as of May this year.
And now the country wants to develop and expand the industry even more.
Currently, most of the clinical trials in Malaysia are phase II and phase III studies, so Malaysia has set its sights on further enhancing the country’s capabilities in early phase or First-In-Human (FIH) trials.
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 animal studies and tests in laboratory.
Clinical Research Malaysia (CRM) has been working on its Phase 1 Realisation Project (P1RP) 2.0 initiative to achieve this goal and it has already shown some results.
In January, Sarawak General Hospital (SGH) was selected by Swiss healthcare giant Roche Pharmaceuticals to be one of its global FIH clinical trial sites, making Malaysia the seventh country included by Roche in the study and the first within the Asia-Pacific region.
Dr Voon Pei Jye, the leading investigator for the trial in Malaysia, says the oncology team at SGH has been involved in many late-phase trials for over a decade.
“However, our team recognised the need to overcome the limitation of focusing solely on late-phase trials and decided to embark on early-phase trials to complete the cycle of comprehensive oncology drug development,” he says.
As this aligned with CRM’s P1RP initiative, he says they received unwavering support from all stakeholders to embark on the journey to establish an FIH team at their Phase I-equipped Clinical Research Centre at SGH.
One of the key things they needed to build the hospital’s capacity was to develop human capabilities in FIH trials.
“I am fortunate to have had the opportunity to learn from one of the best FIH teams globally at the Princess Margaret Cancer Centre in Toronto, Canada, through their esteemed Phase I early drug development clinical research fellowship.
“Upon my return, and with all other initiatives coming together, we initiated our first oncology FIH trial in the country,” he says.
The FIH study Dr Voon is in charge of is evaluating a potent oral compound targeting a specific mutation to treat advanced cancer in patients who have no further standard care options.
Patients from various parts of Malaysia have been enrolled in this trial.
“Overall, the journey of conducting this first FIH trial has been relatively smooth, thanks to the readiness and dedication of the entire team,” Dr Voon says.
With the higher perceived risks of FIH trials, recruiting patients for the trial may be even more difficult than in late-phase trials.
“The process of recruiting patients for FIH trials is similar to that of other trial phases but can often be more challenging due to the higher perceived risks.
“Participants may hesitate to enrol out of concern for potential side effects.
“Overcoming these challenges requires clear and thorough communication about the trial’s purpose, safety measures, and potential benefits,” he says.
Dr Voon assures that FIH trials undergo a much more stringent approval process than late-phase trials.
“FIH trials carry more potential risk since the treatment has only been tested in preclinical studies.
“Later-phase trials have more established safety profiles, which is why FIH trials typically undergo higher regulatory scrutiny due to the inherent risks.”
(From left) CRM chief executive officer Dr Akhmal Yusof, Health Minister Datuk Seri Dr Dzulkefly Ahmad, Health director-general Datuk Dr Muhammad Radzi Abu Hassan and Roche (Malaysia) country medical director Dr Wendy Tay at the announcement of the Sarawak General Hospital as Malaysia’s site for a first-in-human clinical trial in January.
