Research data published in JAMA identify limitations in the post-approval evaluation of drugs awarded accelerated approval by the FDA, ScienceDaily reported Tuesday.
In the study, the investigators examined 22 drugs granted accelerated approval in the US between 2009 and 2013, for which 38 post-approval studies to confirm the safety and efficacy of the treatments were ordered.
The researchers found that only half of the ordered studies had been completed within three years after the drugs' approvals.
The research team also uncovered that many of the confirmatory trials relied on surrogate measures of effect with unclear correlations with real clinical endpoints.
"One might expect accelerated approval confirmatory trials to be much more rigorous than the pre-approval trials," said study author Aaron Kesselheim, adding "but we found that there were few differences in these key design features of the trials conducted before or after approval."
"It is important to use clinical endpoints in testing investigational drugs whenever possible because there are numerous cases of drugs approved on the basis of a surrogate measure that turn out to later not effect actual clinical outcomes -- or even make them worse," Kesselheim continued.
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