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Wednesday, September 28, 2016

The Straits Times Friday, May 27 2011

Online Clinical Trial A Success

BY FENG ZENGKUN

The next big clinical trial in Singapore could be conducted online.

Scientists from the National University Health System (NUHS) have successfully used a website to conduct a trial. They said this method could save time and help scientists track disease patterns during pandemics.

The results of the trial and the method were published in an online edition of medical journal The Lancet earlier this month.

The scientists set up a website during the H1N1 flu pandemic in 2009 and recruited 1,500 patients from Singapore to test a possible anti-flu drug.

Applicants filled out a questionnaire about their illness on the website. Those who qualified for the trial were screened by doctors in real life.

Selected patients were given drugs and taught to monitor their symptoms and record them through the website.

A hotline was provided for questions and in case the patients had adverse reactions to the drugs.

The scientists said they recruited 1,500 patients in three months, less than half the time needed in similar trials in the past.

"A website can check and disqualify far more people than a doctor can at any time," said Dr Gerard Wong, deputy director of the NUHS investigational medicine unit.

Dr Sophia Archuleta, 38, a consultant in the NUHS division of infectious diseases, said the method could help doctors gather information during virus outbreaks.

"If we can track the disease patterns, we can prevent the next outbreak," she said. "But doctors are usually too busy trying to cure people to collect data."

Dr Wong, 51, added that going online can net a wider range of patients from around the world. "For long-term studies, the patients can come to Singapore to get the drugs and go back to their home countries. We can monitor them online."

But the team noted that the online medium meant applicants are skewed towards the younger, more Internet-savvy generation. In the H1N1 trial, 80 per cent of the patients were aged between 18 and 34. "We can mitigate this by having more print advertisements for other trials," Dr Wong said. He added that the bias is likely to lessen as more generations become computer-literate.

Another limitation of the method is that it cannot be used for trials that involve complicated procedures or intensive treatment. Trials that require patients to spend time in the intensive care unit, for example, cannot be monitored online.

The scientists said such customised websites are costly and suitable only for large-scale trials involving hundreds or thousands of patients. Dr Wong said: "If there are only a few patients, seeing a doctor would be faster and cheaper."

But he noted that most drugs have to go through clinical trials that involve at least hundreds of patients before they can be sold on the market. "Using a website would cut down on the cost and time spent on these trials," he said.

The team's research was funded by the National Medical Research Council and endorsed by an anonymous international review panel as part of the process.

The drug, chloroquine, was found to be ineffective against the H1N1 flu strain.

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