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Stopping a cancer trial early: is it for the benefit of patients or industry?
Date:4/8/2008

New research has identified a growing trend for trials of new cancer treatments to be stopped prematurely before the therapies risks and benefits have been properly evaluated.

In a study, published online today (Wednesday 9 April) in the cancer journal, Annals of Oncology [1], Italian researchers analysed 25 randomised controlled clinical trials that had been stopped early because they had started to show a benefit to patients and found that the numbers had increased dramatically in recent years. They warn that 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.

Out of 14 trials stopped because they started to show benefit to patients and published between 2005-2007, the researchers found that 11 (79%) were used to support an application for marketing authorisation at the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA).

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, Dr Giovanni Apolone, one of the authors, told a news briefing yesterday (Tuesday).

Dr Apolone, head of the Laboratory of Translational and Outcome Research in Oncology, Mario Negri Institute for Pharmacological Research, Milan, Italy, continued: When we analysed 25 trials over a ten year period between 1997 and 2007, we found a consistent increase in prematurely stopped trials more than 50% were stopped within the last three years.

We are aware that trials stopped early because they are showing benefit may result in the identification of promising new treatments for patients. However, findings obtained following this strategy should be consi
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Contact: Emma Mason
wordmason@mac.com
07-711-296-986
European Society for Medical Oncology
Source:Eurekalert

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