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Published on 17 October 2008

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Drug trials “should study the past”

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NHS acceptance of new drugs relies too much on randomised control trials, according to the head of the National Institute of Health and Clinical Excellence (NICE).

Sir Michael Rawlins said that new mechanisms are needed to check up on the effectiveness of drugs once they are on the market.

He said that more weight should be given to so-called historical control trials, which compare outcomes from new treatments with those seen in the past.

That might see drugs coming on to the market earlier, he said in a speech to the Royal College of Physicians.

In the randomised control tests, people with a particular medical problem are divided into two groups, one of which is given a new treatment while the other is not. The effectiveness of the treatment is judged by the variance in outcome.

Under the historical method, the experiences of the group receiving the new drug is compared with what might be expected to happen judged by what happened in the past.

Sir Michael accepted there were “dangers” in relying on historical comparisons to judge a new drug’s effectiveness, but added: “We have to be prepared to accept the results of these sorts of studies.”

Copyright PA Business 2008

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