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 SingHealth opens largest early-phase clinical trial unit

31 July 2010

Publication: Strait Times

32-bed centre’s opening marks S’pore’s bid to be hub for clinical studies

By Kimberly Spykerman & Mavis Toh

Singapore General Hospital (SGH) has set up a centre with 32 beds for clinical scientists to conduct early-stage drug trials.

Already, more than 20 trials are going on in the SingHealth Investigational Medicine Unit, with patients and volunteers undergoing tests.

At a cost of $20 million, the unit, which includes laboratories meant for the study of the human body clock and how it works, was officially opened yesterday and marked Singapore’s growing reputation as a place for clinical studies.

Between 2007 and last year, the number of clinical trials here shot up by 60 per cent, a trend mirrored across Asia. Last year, the Health Sciences Authority certified 262 clinical trials. Of these, about a third were for cancer drugs.

There are other such units here, like the one at the National University Hospital. But the SGH unit is the largest in the public sector here. Funds will be pumped into the unit over five years by the Health Ministry’s National Medical Research Council, SingHealth, Duke-NUS Graduate Medical School and the Singapore Institute of Clinical Sciences.

Because the unit has its own beds, clinicians are not subject to vagaries such as a bed crunch, unlike those who have to use beds in the existing wards.

SingHealth’s group director of clinical research, Professor Fong Kok Yong, hopes the set-up will encourage more clinicians to undertake early-phase clinical research. “The earlier phase is where you’re more at the cutting edge as these are the newer therapeutic agents that you want to test and see how they work and react within the human body itself.”

In the early phase of a trial, an experimental drug is tested for the first time in a small group of between 20 and 80 people, to evaluate its safety, determine a safe dosage range, and identify side effects. A full clinical trial has four phases before the drug can be marketed.

Health Minister Khaw Boon Wan said it was important to build up a research culture here. Referring to the pioneer batch of Duke-NUS medical graduates who will enter the field next year, he said: “They have been prepared to be clinician scientists... We don’t expect everyone to make clinical science a career for life, but we certainly hope the vast majority will start the first few years down the clinical science track.”

He said a supportive environment was crucial for progress. “If it’s stifling or destructive, I think that would be terrible. Students would be totally discouraged.”

Professor Soo Khee Chee, deputy CEO of SingHealth, referred to Singapore’s population mix, which gives a good cross-section of people for clinical studies to be done, as a plus. “If a company were to do research in Singapore, it’s like doing it in three different countries – in China, India and Indonesia,” he said.

“And if you couple that with the very high standard of medicine here, whatever clinical trials we do here will be more easily accepted by the regulatory authorities in the United States or Europe than if they were done in other countries.”

Prof Fong said the centre has built up a database with close to 1,000 volunteers. Most of the ongoing trials are for cancer patients, although tests are also going on in fields such as haemotology and infectious diseases.

When The Straits Times visited the unit yesterday, one woman was in the middle of a six-day “jet-lag” trial, which involved large amounts of sleep deprivation, to study the effects of light on the internal body clock.


Trial and error

Clinical drug trials are typically conducted to test the benefits and risks of new drugs and how they best serve the patient.

The Health Sciences Authority regulates the conduct of these trials here, and those interested in starting a study must first obtain a clinical trial certificate.

Most clinical drug trials here are done by senior doctors or specialists in their fields of practice, and in recent years a sizeable number of trials have been in oncology and cardiology. Trials can last up to a year
and are usually conducted on between 20 and 30 people. Before any trial begins, volunteers must be fully briefed on the process of the trial and the risks involved. They also have to sign a consent form after being given a detailed outline of what to expect.

While some trials are done on healthy volunteers, those taking part in certain trials, like for cancer drugs, are usually patients in advanced stages of the disease.

On the success rate of trials in cancer patients, Professor Stan Kaye, a cancer researcher from Britain, said: “Fifteen per cent of patients can have measurable benefits where the cancer shrinks.”


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