Regulatory Focus™ > News Articles > Study: Pediatric Clinical Trials Remain Scarce

Study: Pediatric Clinical Trials Remain Scarce

Posted 25 July 2012 | By

An upcoming study in the medical journal Pediatrics finds pediatric clinical trials to be lacking, especially for conditions where children are well represented among those most likely to benefit from a medical product, reports Reuters.

The study, led by author Dr. Florence Bourgeois, looked at more than 2,400 clinical trials conducted in the last five years and their respective enrollment of children. The studies were notable in that they were all related to conditions for which children make up a significant percentage of potential patients.

"Overall, just 12 percent of the trials focused on children and teenagers. Yet kids accounted for 60 percent of those suffering the conditions studied," explained Reuters.

The authors-perhaps unsurprisingly-found ethical quandaries often dissuaded both parents and companies from enrolling children in studies. Factors such as the hesitancy of parents to subject their child to an untested drug, the unknown safety risks, the inability of the child to fully understand the extend of the clinical testing, and the lack of incentives for industry to pay for the trials all played a role in low enrollment rates, said Bourgeois.

The study comes just as US legislators passed a bundle of reforms for the US Food and Drug Administration (FDA) containing, among other things, provisions that would make permanent both the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). Both pieces of legislation have been in effect for more than a decade, and provide, respectively, the ability for FDA to require sponsors to conduct trials on pediatric populations and additional marketing exclusivity for companies who do so.

While Bourgeois told Reuters it's clear the legislation has helped to reverse decades of neglect in the area of pediatric trials, much work remains to be done. "Children continue to be underrepresented in clinical trials compared with their burden of disease," said Bourgeois.

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Reuters - Study finds scarcity of drug trials in kids

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