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Short trials ‘put patient at risk’


There is a growing trend for trials of new cancer treatments to be cut short before the therapies’ risks and benefits have been properly evaluated, research has claimed.

The findings come after Italian researchers analysed 25 controlled clinical trials between 1997 and 2007 and found the numbers which had been prematurely stopped because they had started to show benefits to the patients had increased dramatically – with more than 50% stopped early within the last three years.

They warned this could lead to a systematic over-statement of the effects of treatment, and that patients could be harmed by new therapies being rushed prematurely into the clinic.

Some 79% (11 out of 14) trials cut short and published between 2005-2007 were used to support an application for marketing authorisation at the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA), the study found.

Dr Giovanni Apolone, one of the study’s authors said: “This suggests a commercial component in stopping trials prematurely.

“In fact, this strategy (i.e. stopping trials early for benefit) could guarantee quicker access to the market for companies.

“On the other hand, a quicker clinical drug development may lead to an ‘immature’ benefit/risk balance of new drugs.”

“Only untruncated trials can provide the full level of evidence required to safely translate treatments into clinical practice. Without such evidence, unsafe and ineffective drugs could be marketed and prescribed, and patients’ health could be jeopardised.”

Copyright © PA Business 2008

European Medicines Agency

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