title: Trends in paediatric clinical pharmacology data in US pharmaceutical labelling.
abstract: BACKGROUND
  There is often a lack of safety and efficacy data in the paediatric population at the time of drug approval. Legislative efforts have promoted clinical pharmacology research in this underserved population. We sought to determine the quantity and quality of paediatric clinical pharmacology data in US drug labelling at the time of initial approval and to evaluate trends over time.
  
  
  METHODS
  The labelling data of 213 new molecular entities approved between 2003 and 2012 were systematically reviewed. The type of paediatric pharmacology data present at the time of approval was recorded and stratified by age group. Labelling revisions were analysed for updated paediatric data. The presence of paediatric-specific black-box warnings was noted.
  
  
  RESULTS
  Of the 213 drugs evaluated, 48 had adult-specific indications. Of the remaining 165 medicines, only 47 (28%) had paediatric study data at the time of initial labelling. The number of approved drugs with paediatric data was the greatest in 2005 (8, 44%) and was at its lowest point in 2012 (3, 11%). Only five medicines had neonatal data, with none of the anti-infective agents presenting neonatal information. Seven medications had a paediatric-specific black-box warning. Additional 16 medicines presented paediatric data during general labelling updates.
  
  
  CONCLUSIONS
  Despite efforts to improve the quality of paediatric clinical pharmacology data, there was not a significant increase in drugs with paediatric data at the time of approval over this 10-year study period. Paediatric drug approvals and labelling revisions continue to lag behind their adult counterparts.
authors: Center for Translational Science, Children's National Medical Center, Washington, DC, USA Division of Pediatric Clinical Pharmacology, Children's National Medical Center, Washington, DC, USA Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
authors: Samira
authors: S
authors: Samiee-Zafarghandy
authors: Center for Translational Science, Children's National Medical Center, Washington, DC, USA Division of Pediatric Clinical Pharmacology, Children's National Medical Center, Washington, DC, USA Department of Emergency Medicine, George Washington University, Washington, DC, USA.
authors: Maryann
authors: M
authors: Mazer-Amirshahi
authors: Center for Translational Science, Children's National Medical Center, Washington, DC, USA Division of Pediatric Clinical Pharmacology, Children's National Medical Center, Washington, DC, USA Department of Pediatrics, George Washington University, Washington, DC, USA Department of Intensive Care, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands Department of Paediatric Pharmacology, University Children's Hospital Basel, Switzerland.
authors: Johannes N
authors: JN
authors: van den Anker
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D017277:Drug Approval / Q000706:statistics & numerical data*; D004348:Drug Labeling / Q000706:statistics & numerical data*; D006801:Humans; D010372:Pediatrics; D010601:Pharmacology, Clinical / Q000706:statistics & numerical data* / Q000639:trends; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration
keywords: Paediatric Practice; Pharmacology