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Cancer Drug Trials Often Halted Early
An increasing number of clinical trials for new cancer treatments are being halted before the risks and benefits have been fully evaluated, say Italian researchers, who warn that this growing trend could put patients at risk of harm from new therapies rushed into use.
The researchers looked at 25 randomized, controlled clinical trials that were stopped early because the treatments had started to show benefit to patients.
"When we analyzed 25 trials over a 10-year period between 1997 and 2007, we found a consistent increase in prematurely stopped trials - more than 50 percent were stopped within the last three years," study co-author Giovanni Apolone said at a news conference 14 trials halted early and published between 2005 and 2007, the researchers found that 11 79 percent of them were used to support drug approval applications submitted to the European Medicines Agency and the . Food and Drug Administration.
"This suggests a strong 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," Apolone said.
He and his colleagues "are aware that trials stopped early because they are showing benefit may result in identification of promising new treatments for patients. However, findings obtained following this strategy should be considered to be preliminary results that require subsequent confirmation."
It can take several years for the long-term benefits or harmful side effects of a new treatment to become apparent, Apolone noted, but the average duration (持续时间) of the 25 studies he and his colleagues analyzed was 30 months, with a range f