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

Full Text via DOI: 10.1016/j.cct.2016.03.002 PMID: 26968616 Web of Science: 000374606900048

Cited authors

  • England, Amanda; Wade, Kelly; Smith, P. Brian; Berezny, Katherine; Laughon, Matthew


  • 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 FIN is optimizing operational efficiencies in pediatric drug trials to increase the safety of drugs in children. (C) 2016 Elsevier Inc. All rights reserved.

Publication date

  • 2016

Published in

International Standard Serial Number (ISSN)

  • 1551-7144

Start page

  • 376

End page

  • 382


  • 47