title: Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience.
abstract: Performing drug trials in pediatrics is challenging. In support of the Best Pharmaceuticals for Children Act, the Eunice Kennedy Shriver National Institute of Child Health and Human Development funded the formation of the Pediatric Trials Network (PTN) in 2010. Since its inception, the PTN has developed strategies to increase both efficiency and safety of pediatric drug trials. Through use of innovative techniques such as sparse and scavenged blood sampling as well as opportunistic study design, participation in trials has grown. The PTN has also strived to improve consistency of adverse event reporting in neonatal drug trials through the development of a standardized adverse event table. We review how the PTN is optimizing operational efficiencies in pediatric drug trials to increase the safety of drugs in children.
authors.affiliation: Division of Neonatal-Perinatal Medicine, The University of North Carolina at Chapel Hill, N.C. Memorial Hospital, 101 Manning Drive, CB#7596, Chapel Hill, NC 27599-7596, USA.
authors.forename: Amanda
authors.initials: A
authors.lastname: England
authors.affiliation: Division of Neonatology, Children's Hospital of Pennsylvania, CHOP Newborn Care at the Hospital of the University of Pennsylvania, 800 Spruce St., Philadelphia, PA 19107, USA.
authors.forename: Kelly
authors.initials: K
authors.lastname: Wade
authors.affiliation: Department of Pediatrics, Duke University School of Medicine, Durham, NC 27710, USA; Duke Clinical Research Institute, Duke University School of Medicine, P.O. Box 17969, Durham, NC 27715, USA.
authors.forename: P Brian
authors.initials: PB
authors.lastname: Smith
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, P.O. Box 17969, Durham, NC 27715, USA.
authors.forename: Katherine
authors.initials: K
authors.lastname: Berezny
authors.affiliation: Division of Neonatal-Perinatal Medicine, The University of North Carolina at Chapel Hill, N.C. Memorial Hospital, 101 Manning Drive, CB#7596, Chapel Hill, NC 27599-7596, USA. Electronic address: matt_laughon@med.unc.edu.
authors.forename: Matthew
authors.initials: M
authors.lastname: Laughon
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods / Q000458:organization & administration*; D004358:Drug Therapy; D017598:Efficiency, Organizational; D006801:Humans; D000070516:Intersectoral Collaboration; D015337:Multicenter Studies as Topic / Q000379:methods; D061214:Patient Safety; D010372:Pediatrics; D012107:Research Design; D014481:United States
keywords: Adverse events; Organizational improvements; Pediatric drug trials