Clinical trials are a crucial part of the process to develop novel life-saving treatments, with safeguards in place to protect trial volunteers.

The development of groundbreaking vaccines and treatments during the COVID-19 outbreak has thrust clinical trials into the spotlight. However, clinical studies have played a critical role in modern medicine long before the pandemic. Clinical trials are an essential step in the process of discovery of new life-saving treatments.

“A clinical trial is a research study where a new treatment, which can be a drug, vaccine or even a novel therapy, is evaluated in human subjects before it is used in clinical practice,” said Dr Matthew Ng (pictured below), Clinical and Scientific Director, SingHealth Investigational Medicine Unit (IMU), a dedicated early-phase clinical research unit.

While some clinical trials provide access to promising investigational therapies and hope to patients who may not be responding well to existing standard treatments, other studies are non-interventional, such as those that collect data to understand disease patterns, Dr Ng said.

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Professor Lo Yew Long (pictured below), Group Director, Research (Research Integrity, Compliance & Ethics), SingHealth, who is the former Chairman of SingHealth Centralised Institutional Review Board (CIRB), said, “Clinical trials also add to incremental knowledge in understanding, monitoring and diagnosing medical conditions. They are informative and are meant to benefit society.”

The SingHealth CIRB currently oversees 2,500 active research studies, of which about 300 are ongoing clinical trials. It is an independent ethics committee responsible for approving, monitoring and reviewing biomedical and behavioural research involving humans for institutions under its oversight.

At SingHealth IMU, there are about 50 ongoing early-phase clinical trials in various therapeutic areas such as oncology, endocrinology, infectious diseases and renal medicine.

Among them is a clinical trial to evaluate the safety and immune response of a novel mRNA vaccine targeting several COVID-19 variants. According to Dr Ng, there are also ongoing trials in the field of oncology that are looking at newer types of immunotherapy.

Different phases of trials

Prof Lo explained that clinical trials are conducted in a few phases, some of which can take as long as several years before they are used in clinical practice.

In early-phase clinical trials, new treatments are studied for the first time in humans. The later phases aim to confirm the findings in a larger group of volunteers over a longer period of time.

The duration of each clinical trial varies, depending on several factors. “For healthy volunteer trials that involve vaccines or new drugs that are at the dose-determining and safety stage, it could be as short as six to seven months, which was the case with COVID-19 vaccine trials,” said Ms Sue Tee (pictured below), Administration and Operations Director, SingHealth IMU.

“An oncology trial, for example, could last an average of seven to 10 years, and those involving large participant numbers could take more than 10 years,” she added.

Safeguards in place

The perception that patients are being ‘guinea pigs’ when they take part in a trial is becoming less common in Singapore, said Dr Ng.

“The younger generation is more open to clinical trials. With information available online, some have even approached us seeking trials suitable for them,” he explained.

Regardless of the type of clinical trial and the phase, safeguards are in place to protect trial participants’ welfare. All clinical trials in Singapore are regulated by the Health Sciences Authority.

Before commencing, clinical trials are reviewed and approved by an Institutional Review Board (IRB), said Prof Lo. “There is a team of staff who looks at the compliance of the investigators, who have the duty to report any observations and side effects to the authorities and the IRB. Regular audits are carried out to ensure that compliance, side effects or unexpected events are reported in a timely manner.”

Informed consent

All trial volunteers are given an informed consent form, which states the benefits and risks of participating in the trial.

“The informed consent form tells the patients the purpose of the trial, their suitability, and what is required of them during trial. For example, how much blood will be taken, and how many scans and follow-ups are needed,” Dr Ng said.

“Importantly, it also informs participants that they have the right to withdraw from the study at any point, and it will not prejudice subsequent medical care.”

While participants can withdraw from a clinical trial at any time, the experts highlight that it is important for participants to carefully consider their reasons for taking part and whether they can remain committed prior to enrolling in a trial, especially as some trials can take a long time to complete.

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