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Children Continue to Be Underrepresented in Drug Trials

Last Updated: July 23, 2012.

Even for conditions with a high pediatric disease burden, only a small proportion of clinical drug trials study pediatric patients, according to research published online July 23 in Pediatrics.

MONDAY, July 23 (HealthDay News) -- Even for conditions with a high pediatric disease burden, only a small proportion of clinical drug trials study pediatric patients, according to research published online July 23 in Pediatrics.

Florence T. Bourgeois, M.D., M.P.H., from Harvard University in Boston, and colleagues identified all drug trials registered in ClinicalTrials.gov with start dates between 2006 and 2011 and tracked the resulting publications for conditions with a high burden of pediatric disease.

The researchers found that, for the selected conditions, 59.9 percent of the disease burden was seen in children, but only 292 of 2,440 trials (12.0 percent) were for pediatric patients (P < 0.001). Trials conducted without industry funding were significantly more common in pediatric populations compared with adults (58.6 versus 35.0 percent). Pediatric randomized trials were significantly less likely to examine safety outcomes compared with adult randomized trials (10.1 versus 16.9 percent) and had a modestly higher probability of publication in the examined time frame (32.8 versus 23.2 percent; P = 0.04).

"There is substantial discrepancy between pediatric burden of disease and the amount of clinical trial research devoted to pediatric populations," the authors write. "This may be related in part to trial funding, with pediatric trials relying primarily on government and nonprofit organizations."

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