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." 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.
Ward
R M
RM
Pediatric Pharmacology Program, Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA. robert.ward@hsc.utah.edu
Kern
S E
SE
D002986:Clinical Trials as Topic; D003257:Consumer Product Safety; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy*; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D018570:Risk Assessment; D016896:Treatment Outcome