Few labeling changes to include infant information have been made since the passage of federal legislation encouraging the study of drugs in pediatric patients, according to recent study results published in JAMA Pediatrics.
“Studying drugs in neonates is critical; however, because of scientific and regulatory challenges, trials involving neonates are scant,” the researchers wrote. “The rapid psychological changes in the developing neonate affect study design and endpoint. Study designs and procedures that are appropriate in adults and older children may not be appropriate in neonates. Extrapolation of efficacy from adults or older pediatric populations — a tool that can sometimes be used to decrease the ‘trial burden’ for the pediatric population — is less easily adapted to the neonate.”
Full Story »