Without thorough review, Italian study says the trend poses risks to patients
FRIDAY, April 11 (HealthDay News) -- 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 Tuesday.
Of 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 U.S. 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. We believe that 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 jeopardized."
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