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 Why clinical trials need volunteers


16 April 2009


Publication: Lianhe Zaobao

New drugs and treatment are constantly being discovered. For these to reach the man in the street, clinical trials have to be conducted first and this is where you can help. JUNE CHEONG reports.

Clinical trials here need people like you. Yes, you.

Dr Tal Burt, the director of the Investigational Medicine Unit at Singapore Health Services, said: “The scientific preference is to study healthy individuals in the first stages of a trial. If not, two elements – your illness and the new drug being tested – can affect the trial results.”

He added: “Currently the only niche group we reach out to is what we call professional volunteers. I prefer to get people from all walks of life.
“Medical research is an endeavour for society and everyone can benefit from it, so everyone should have an interest in it.”

Clinical trials are part of the process of medical research and are often requisite in applications to distribute or market a new drug or treatment commercially.

These trials, typically spanning three to four phases, evaluate the efficacy and safety of new medications or devices by observing their effects on randomised groups of people.

Phase 1: These trials usually involve healthy volunteers.

Phase 2: These are conducted on patients.

Phase 3: These involve patients in larger numbers to confirm the effectiveness and monitor the side effects of the new drug or treatment being studied.

Phase 4: These trials are studies done after a drug or treatment has been approved for use to find out more about the drug’s risks, benefits and optimal use.

The exception is cancer drug trials, where patients are inducted from the start.

It can take five to eight years for a new drug or treatment to move from clinical trials to commercial use.

With each progressive phase, doctors require larger pools of participants, from 20 to 80 subjects in Phase 1 trials to hundreds and even thousands in Phase 3 trials.

Dr Burt explained: “Once you’ve observed something over and over, you get a certain confidence that the results are real. The more times it happens, the more reassured you are that the results are replicable.”

There are various kinds of clinical trials, including treatment trials which study experimental types of treatment or new drugs and prevention trials which look for better ways to prevent disease in people.

In recent years, more clinical trials have been conducted in Asia.

The number of drug trials certified by Singapore’s Health Sciences Authority in 2006 was 217. In 2000, the number was 157.

Associate Professor Goh Yeow Tee, a senior consultant in the department of haematology, head of bone marrow transplant and the director of Clinical Trials Resource Centre at Singapore General Hospital, explained: “More pharmaceutical companies have realised that the majority of the world population is here and this is the place to go.”

Despite the medical industry’s newfound enthusiasm for Asia, the reaction of the man in the street is decidedly more muted.

Professor Wong Tien Yin, the director of the Singapore Eye Research Institute and a senior consultant in vitreo-retinal service at Singapore National Eye Centre, said: “In Asia, the perception of people who take part in clinical trials is that they are guinea pigs. In fact, clinical trials are very sophisticated extensions of current treatment.”

One person who had her fears about participating in a clinical trial eased is housewife Angie Ng, 43.

She was diagnosed with chronic myeloid leukaemia in January last year and was invited to take part in a Phase 3 trial of a new drug.

Although concerned about the possible side effects, she agreed to take part as the cost of treatment and medication would be borne by the medical team.

She said: “There are risks because you don’t know how your body will take it but risks are part of life. I took a leap of faith.”

For the first three months, she suffered side effects like see-sawing levels of red and white blood cells, giddiness, shortness of breath, tiredness and water retention.

Six months into the trial, the new drug helped to stabilise her condition. She is now in remission.

She said: “The experience was quite pleasant because I had a great doctor who was very reassuring and made sure whatever concerns I had were dealt with. There’s also a coordinator who follows your progress throughout the whole trial.

“I was treated like a first-class patient. Sometimes we hold back (on taking part in such trials) because we think we’ll be the guinea pigs.

“But by going for the trial, you know you’ve got people looking into your results and you’re helping medical science to advance.”

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WANT TO TAKE PART IN A CLINICAL TRIAL?

Here’s what you should know:

WHO CAN VOLUNTEER

- Phase 1 trials: Healthy individuals aged 18 to 65 years.

Dr Tal Burt, the director of Singapore Health Services’ Investigational Medicine Unit, explained: “There are not that many physiological changes in adults and it’s quite a homogeneous distribution across the ages.”

- All other trials: Patients with relevant illnesses or ailments.

WHY YOU SHOULD VOLUNTEER

- To help further medical research.

- You can expect more personalised and intensive medical care as trial doctors and staff monitor your condition closely and constantly.

- You are paid $100 to $200 per visit during the trial.

- You gain access to new drugs or new types of treatment before they are available.

- Sometimes clinical trial patients can get the new drug or treatment more cheaply when it is licensed and is commercially available.

DRAWBACKS

- There may be possible side effects.

- There may be risks in the new drug or treatment which cannot be predicted.

- There will be frequent follow-up appointments during the trial period.



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