Friday, March 19, 2010

Independent board to look into clinical trials

medical_report

SINGAPORE - Injecting stem cells under the skin to make a person look younger, or using platelet-rich plasma to treat acne scars - could such procedures soon become accepted aesthetic treatments?

These experimental therapies are some of the clinical trials a new independent review board is looking into.

Set up by the Society of Aesthetic Medicine (Singapore) (SAM), the Create Independent Review Board is the first independent review board, not based in an institution, in South-east Asia.

It targets the independent private practitioner, who now either goes to a hospital's review board or direct to a relevant authority, such the Ministry of Health or Health Sciences Authority, for regulatory approval to conduct a clinical trial.

In such cases, the HSA could sometimes end up referring the doctor back to a review board, said Dr Tan Kok Leong, SAM's honorary treasurer.

By SAM's estimates, doctors will have to pay around $5,000 to the independent board to cover its cost, compared to the estimated $15,000 price tag at other review panels.

But like the other review boards, if this new group approves a trial, the application will then be submitted to a regulatory body. The board will also review the trial at every stage, and if there is strong evidence the therapy works, it will be published in peer-reviewed journals.

Honorary secretary of SAM David Loh said the board will help "sieve out the less suitable" trials and "at every stage of the clinical trial, there's an independent oversight, there's reassurance, there are multi-layers of safeguards and scrutiny".

"We want to be at the forefront (of the aesthetics field), but also want to be safe," he added.

Formed about a year ago, the board will have its official launch on Sunday. Currently, it has 12 members. At least five of these members will be selected to discuss a clinical trial. Two of the five also have to be non-doctors with at least a tertiary education, for instance a lawyer or accountant.

So far, two clinical trials have been approved by the board, including the world's first trial using platelet-rich plasma to treat wrinkles and acne scars. This was approved by HSA in January. Another three clinical trials are currently being reviewed by the board.

For now, the board will only review applications from SAM members but it hopes to expand the service to all other practitioners in future.

However, it remains to be seen if this will encourage more clinical trials among doctors.

Dr Yeak Hwee Lee from Singapore Aesthetic Centre felt the $5,000 fee may still be too expensive for some doctors, while Dr Benjamin Yim, a general practitioner with an interest in aesthetics, said it was "not practical" for him as a solo practitioner since he does not have the resources to conduct clinical trials.

However, Dr Yim does see the value of such trials in substantiating aesthetic treatments with "soft evidence".

"With the objective of it (the clinical trial) being done in a professional and safe way, I think it's good," he said.

In 2008, guidelines on aesthetic practices came into effect. Seven treatments, including mesotherapy and carboxytherapy, were deemed to have low levels of evidence and were allowed only as clinical trials or a series of before-and-after studies. Doctors intending to perform other aesthetic treatments that have not been classified as well-established and acceptable by MOH will also have to gain regulatory approval.

[SOURCE: http://www.todayonline.com]

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