A new study suggests that drug trials involving children get shockingly little oversight from outside safety monitoring groups. The study, which reviewed 739 international trials mounted between 1996 and 2002, concluded that only one of every 50 such drug trials were overseen by outside safety groups. Of those that did use monitoring groups, six were stopped because of signs of toxicity. Also, adverse side effects were reported in 37 percent of all trials, and about one in ten produced moderate to severe--and sometimes life-threatening--side effects.
Why such a lapse in oversight? Experts note that drug trials for children are, themselves, a relatively new thing. In the past, children have been given the same medicines as adults without there having been any separate trials, despite the differing metabolisms.
To learn more about this research:
- read this FierceBiotech piece
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