Saturday, March 26, 2011

Budget boost for clinical trials

Ben Goldacre, The Guardian, Saturday 26 March 2011:

Very occasionally, a government will do something awesomely good. The budget contains plans for a unified Health Research Regulatory Agency to streamline the regulations on clinical trials, and so make them cheaper and easier to run.

It's motivated, disappointingly, by a desire to make the UK a more attractive location for commercial trials. But this is the first time a government has shown signs of seriously addressing one of the most serious ethical problems in medicine: the harm done to patients by ethics committees and regulators.

There is a bizarre paradox in medicine. When there is no evidence on which treatment is best, out of two available options, then you can choose one randomly and be subject to no special safeguards.

If, however, you decide to randomise and so generate new knowledge to improve treatments, then a world of administrative obstruction opens up.

This is not an abstract problem. Here is one example. For years in A&E, patients with serious head injuries were often treated with steroids, in the reasonable belief this would reduce swelling, and so reduce crushing damage to the brain.

But researchers wanted to randomise unconscious patients receiving steroids, or no steroids. to find out which was most effective. This was called the CRASH trial, a famously hard-fought battle with ethics committees, even though both treatments – steroids and no steroids – were in routine use. When approval was granted, it turned out steroids were killing patients.

Only a trial could give us this information. Head injury is common. Patients died unnecessarily while we waited for this trial to be approved.

But it wasn't just the delay to getting the trial approved. Read more>>

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