Clinical Trials in Neonates: A Therapeutic Imperative

The lack of study of medications in pediatric patients has been recognized since the 1960s, when Shirkey described children as "therapeutic orphans."(1) In 1968, only 25% of approved drugs included adequate pediatric prescribing information on the label. This did not begin to improve until the 1990s, with the 1997 US Food and Drug administration (FDA) modernization act, the Best pharmaceuticals for Children acts, and the pediatric research equity acts. By 2009, more than 300 labeling changes improved pediatric prescribing information, but newborns were seldom included.