Navigating the Frontiers of Clinical Research

IT all started with a single file cabinet at the Sarawak General Hospital (SGH) for Dr Chew Lee Ping.

Back in 2004, clinical research was still in its infancy in Malaysia.

At that time, there were no dedicated centres or areas in the hospital reserved for clinical research, so everything Dr Chew had related to research was limited to that single file cabinet in her small office.

Now, 20 years later, Dr Chew is the deputy director at SGH’s dedicated clinical research centre, with a small laboratory, cold storage spaces for samples, patient monitoring wards, and administrative offices, among other facilities.

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The journey of clinical research at SGH would not have been possible without support from the government, which realised the potential of this industry as early as 2012 when they set up Clinical Research Malaysia (CRM) to help facilitate the growth of clinical research in the country.

In April this year, Prime Minister Datuk Seri Anwar Ibrahim put an even bigger emphasis on this when he expressed intentions to prioritise efforts to make Malaysia a regional hub for clinical research to grasp the opportunities that this billion-dollar industry can bring.

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But despite the strides Malaysia has made in facilitating clinical research in the country since the days of Dr Chew’s single file cabinet, there are still many challenges faced by researchers which will need to be addressed if Malaysia truly wants to become a regional hub.

Never enough people

While Dr Chew now has more space for clinical research, human resources remain an ongoing problem.

Doctors involved in clinical research in public hospitals are still “service doctors”, meaning they still have normal duties in the hospitals.

“So those who are doing research are actually putting in more effort than what is required of them.

“Our pay bracket doesn’t increase by doing research. Many doctors don’t get involved in research because there is no recognition or pay rise associated with research.

“So I call this [clinical research] as more of my hobby actually,” Dr Chew adds with a laugh.

But while she remains good-natured about it, she reveals she often comes in early or stays back late after her official service duties are over so she can work on her clinical research.

On top of that, it is not an easy task to train doctors to become qualified clinical investigators.

“In Malaysia, we still lack experienced doctors, as experienced clinical investigators take time to produce.

“Once these experienced doctors are well-trained, it is time for them to retire or maybe they quit for private practice. So we lose experienced people in research,” Dr Chew tells Sunday Star.

This problem appears to be widespread as it is also shared by Dr Muthukkumaran Thia-garajan, an oncologist and clinical investigator based at Hospital Kuala Lumpur.

He says it’s not just experienced doctors they need, but study coordinators and nurses as well.

“However, due to various factors, we have to face a high turnover rate and such constant teaching and human resource development activity is exhausting, and of course, sometimes highly disappointing.

“We train good staff but we lose them to greener pastures,” he says.

CRM, the one-stop facilitator for clinical research in Malaysia, is well aware of the lack of human resources, which is why it says training people is one of its main focus.

To that end, it has established a Centre of Excellence to train new graduates in clinical research, among their many other efforts.

“We also work with partners all over the world as far as North America, such as the Princess Margaret Cancer Centre [in Canada], which is one of the top five cancer research centres in the world.

“CRM put in investment to send people for training in those centres,” says CRM chief executive officer Dr Akhmal Yusof.

Dr Akhmal also prefers to look at the silver lining when it comes to people leaving for the private sector – since these are people who received their training in clinical research under CRM, it means CRM can grow their network to entice more companies to sponsor clinical trials in Malaysia, he says.

Busting the ‘lab rat’ myth

While clinical investigators are needed to run the trials, equally as important are the participants who volunteer to join the trials.

On this end, the most oft- repeated issue the investigators run into is the persistent “guinea pig” or “lab rat” myth.

Dr Chew laments that many patients feel more assured buying “supplements” from online stores based on someone else’s testimonials than taking part in “real science in research”.

“They’ll say, why do you want me to be a lab rat? But taking stuff off the Internet is even more dangerous as nobody checks the body’s response to taking the supplement, yet many patients are sceptical about joining true clinical trials,” she says.

Other investigators stress that the trials have extensive safeguards in place.

Dr Voon Pei Jye, a clinical investigator at SGH, says clinical trials also undergo stringent oversight by ethics committees and national regulatory bodies.

“It’s important to communicate that, while all trials carry some risk, they are conducted with rigorous safety protocols including close monitoring and predefined stopping criteria in case of adverse effects,” he says.

The investigators point out that patients can also choose to drop out of a trial at any point in time for any reason.

They also say that hearing testimonials from fellow patients is one of the most effective ways to reassure patients about joining a trial.

While the investigators can do their part in recruiting patients for clinical trials by referring suitable patients who fit the trials’ profiles and explaining the safety procedures and the potential benefits to the patients, ultimately, raising awareness in the general populace is beyond them.

This is where CRM and the government need to step in.

CRM regularly holds awareness campaigns on clinical research and trials in Malaysia, including its ongoing “I Am Aware” campaign.

“We do this around four to six times a year where we go to all areas in Malaysia and educate people and doctors about clinical research, and this programme actually helps in terms of creating that awareness,” Dr Akhmal says.

CRM also has a website that lists all ongoing clinical trials that are recruiting patients in Malaysia.

“So anyone interested can register themselves and we will reach out to them.”

Sourced from The Sunday Star, 3 November 2024