Cancer drug trials stopped "before risks and benefits have been properly evaluated"

A study published in the April 9 on-line issue of the Annals of Oncology shows that the number of cancer drug trials stopped early because they demonstrated a benefit has increased dramatically in recent years. A team of Italian researchers found this trend in an analysis of 25 randomized controlled clinical trials and warn that it could lead to a systematic over-statement of the effects of treatment, with patients potentially harmed by new therapies whose risks have not been properly evaluated.

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

"This suggests a commercial component in stopping trials prematurely. In fact, this strategy 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," one of the study authors, Giovanni Apolone, told a press conference.