Tests and trials

Priya Kulasagaran finds out about what clinical trials entail, and how Malaysia hopes to be a hub for such research in the near future.

As she tells the story of her cancer diagnosis, Norhizan Abdul Rahman quietly broke down in tears. “With the grace of God, I’m now living a normal life; it is a gift,” said the 69-year-old. “I was first diagnosed with lung cancer in 2007, and it was unexpected because there were no symptoms. I had gone in for something else, and they discovered a growth; I learnt I had stage three lung cancer.”

In the harrowing period of coming to terms with the diagnosis, Norhizan found support and strength from her family. “My husband motivated me to carry on, and I chose to not give up hope,” she explains. “It was around the time that I was told about a clinical research trial for a new sort of treatment. After discussing it with my family and doctors, and undergoing some screenings to confirm that I was suitable for the treatment, I decided to go for it. I had to go in for checks to monitor my progress, and to see if I was responding well to the drugs, and thankfully everything went well for me.”

Norhizan was sharing her tale as part of a talk titled “Clinical Trials: The Misunderstood Healthcare Link” held earlier this year. Organised by Clinical Research Malaysia (CRM), the session aimed to highlight the importance of clinical trials for the furthering of new medical treatment, as well as their potential for current patients.

An agency under the Health Ministry’s purview, CRM has been tasked with spearheading and overseeing clinical research in Malaysia, including running trials for multinational pharmaceutical companies. The current global market for clinical research is said to be valued at US$31.5 billion a year (approximately RM132 billion), and it appears that the Malaysian government is keen to have a slice of this pie.

CRM’s business development head Dr Khairul Faizi Khalid said that Malaysia had the right facilities, demographics and ecosystem to make the country a hub for clinical trials in the region. “We’ve seen a 57% increase in clinical trials in the past four years and our goal is to carry out over 1,000 trials by 2020,” he said in his presentation. “With our ethnically diverse genetic background, and prevalence of common diseases such as cardiovascular disease and diabetes, this is a good setup for research. Before this, these trials would usually start in Singapore, and then be moved to Malaysia mid-way due to the lack of recruits. Now we’re aiming to get more researchers to start here in the first place.”

Sharing CRM’s achievements from its 2016 annual report, Dr Khairul added that a growth in the field would also introduce more skilled jobs in the country. “Last year alone, we managed to bring in RM196 million in revenue, and produce 1,491 skilled job opportunities. What we need to do now is to engage more doctors in research, and build up our pool of talent,” he said.

Testing ethics

An integral part of modern medicine, clinical trials are conducted to collect data regarding the safety and efficacy of new drugs, treatments or and devices. Following laboratory research, usually involving testing on animals and human cells, experimental treatments are then carried out on people in four broad phases.

In the initial Phase I studies, the drug or treatment in question is tested for safety. Healthy volunteers are recruited to determine the effects of the treatment, including its possible side effects. Phase II studies meanwhile, assess the efficacy of the treatment by conducting randomised trials.

These blind tests are scaled up to involve thousands of patients in Phase III studies, and these studies can last for several years. If Phase III studies prove to be successful, the drug may be approved for sale. The final Phase IV studies carry on as the drug goes on the market, to compare it with existing treatment methods and to monitor its long-term efficacy and effects.

Aside from offering Malaysians new treatment options, CRM chief executive officer Dr Mohd Akmal Yusof believes clinical trials also provide local medical doctors the chance to study novel drugs and treatment. “Rather than just being a site for trials, we’re looking at knowledge transfer as well. This is both in terms of scientific expertise, as well as gaining experience in carrying out such research,” he said.

In a field where people are test subjects, medical ethics and strict regulation becomes an even more important consideration — and horror stories of trials gone wrong are not unheard of. In 2016, the death of a man and the hospitalisation of five others who were part of a Phase I trial in France shone a spotlight on the potential hazards. The trial, involving an experimental pain drug, initially showed no side effects in humans, but things took a bad turn when dosages were increased. The drug has since been abandoned, and both French and European authorities have tightened their regulations for “first-in-human” trials.

Similarly, Dr Mohd Akmal shared that CRM is committed to the highest standards of safety and ethics of trials carried out here. “In the first place, we scrutinise the sort of trials that are allowed to be conducted; companies need to justify the study and prove that it is safe for patients. Both the Malaysian National Pharmaceutical Regulatory Agency and the National Research Ethics Committee, who regulate trials here, require all pre-clinical and clinical data to make sure the treatment can be tested on humans.”

He added that the agency was stringent about participant selection, and only selected patients are allowed to take part in trials. Aside from travel allowances, participants are also not paid, to prevent possible exploitation of patients. “We also require the pharmaceutical companies to pay for the full course of treatment, beyond just the clinical trial stage,” he said.

Norhizan shared that some of her fellow test subjects had developed reactions to treatment, such as skin rashes. “Aside from the frequent follow-ups, we were told to report any side-effects or symptoms. I was told that the minute anything seemed off, the doctors would intervene or stop treatment. So I didn’t feel worried about continuing,” she added.

Meanwhile, Dr Khairul stressed that transparency is a big part of ensuring a patient’s rights. “This means clear explanation of the treatment, and managing expectations too since there is no certainty that of a ‘cure’. All the consent forms are given in plain layman’s terms so the patient can understand what they’re taking part in. The patient’s well-being is the top priority,” he said.

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