Summary

The NIH reports that 70% of medicines given to children have only been studied in adults; therefore, most drugs used to treat diseases in children are used off-label—without an adequate understanding of the appropriate dose, safety, or efficacy. Off-label prescribing has become the treatment of choice because of the lack of clinical trials in the pediatric population. Compounding this issue are the unique challenges of conducting studies in the pediatric population.

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Center for Pediatric Clinical Development