'Accelerated approval' drugs: How well are they studied? - (ScienceDaily via NewsPoints Desk)

  • 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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