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Pediatric Clinical Trials Dangerous Due to Inappropriate Assessment Measurements

Filed May 1st, 2008 amy

Clinical drug trials that enroll children aren’t doing a very good job of considering the appropriate assessment measurements, research done by the University of Liverpool finds. Prescription medications safe for a healthy adult could be to a child, because kids metabolize medication differently. University of Liverpool researchers reviewed 9,000 pediatric clinical trials conducted since 1950 and found that few studies have involved parents, and none have involved children in the process to select which measurements to use in assessing clinical trials.

As HealthDay News reported Tuesday, children’s bodies handle drugs very differently than adults’ bodies, and it can’t be assumed that drugs that work in adults can simply be used in smaller doses to treat children. Pediatric clinical trials need to be designed with these differences in mind.

University of Liverpool researchers found that out of 9,000 studies, only 25 met the criteria established by the review and examined the selection of outcomes in clinical research in children. The 25 studies came from 13 groups researching a number of conditions, including asthma, cystic fibrosis and Crohn’s disease. However, for many conditions that affect children, there has been no work done into the selection of appropriate outcomes for pediatric clinical trials, the review authors said.

Isn’t it bad enough we’re using adults as guinea pigs with clinical trials for defective and dangerous drugs that end up killing dozens of people before a recall ever even becomes a discussion at the FDA, without putting children at an even heightened risk for being killed or severely sickened by clinical trials that don’t even have proper standards in place?

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