Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience

Contemp Clin Trials. 2016 Mar;47:376-82. doi: 10.1016/j.cct.2016.03.002. Epub 2016 Mar 9.

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.

Keywords: Adverse events; Organizational improvements; Pediatric drug trials.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adverse Drug Reaction Reporting Systems / organization & administration
  • Child
  • Clinical Trials as Topic / methods
  • Clinical Trials as Topic / organization & administration*
  • Drug Therapy*
  • Efficiency, Organizational
  • Humans
  • Intersectoral Collaboration
  • Multicenter Studies as Topic / methods
  • Patient Safety
  • Pediatrics*
  • Research Design
  • United States