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

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • England, A; Wade, K; Smith, PB; Berezny, K; Laughon, M; Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee,

Published Date

  • March 2016

Published In

Volume / Issue

  • 47 /

Start / End Page

  • 376 - 382

PubMed ID

  • 26968616

Pubmed Central ID

  • PMC4997801

Electronic International Standard Serial Number (EISSN)

  • 1559-2030

Digital Object Identifier (DOI)

  • 10.1016/j.cct.2016.03.002


  • eng

Conference Location

  • United States