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

Amanda England1, Kelly Wade2, P Brian Smith3

  • 1Division 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.

Contemporary Clinical Trials
|March 13, 2016
PubMed

Insights

The Pediatric Trials Network (PTN) enhances pediatric drug trial efficiency and safety. Innovative methods like sparse sampling and standardized adverse event reporting improve participation and drug safety in children.

Area of Science:

  • Pediatric Pharmacology
  • Clinical Trial Design
  • Drug Safety in Children

Background:

  • Pediatric drug trials present unique challenges.
  • The Eunice Kennedy Shriver National Institute of Child Health and Human Development established the Pediatric Trials Network (PTN) in 2010.
  • The PTN aims to improve pediatric drug development.

Purpose of the Study:

  • To review the strategies employed by the PTN to optimize operational efficiencies in pediatric drug trials.
  • To highlight methods that increase both the efficiency and safety of pediatric drug trials.
  • To discuss improvements in adverse event reporting for neonatal drug trials.

Main Methods:

  • Implementation of innovative techniques such as sparse and scavenged blood sampling.
  • Utilizing opportunistic study designs to increase trial participation.
  • Development of a standardized adverse event table for neonatal drug trials.

Main Results:

  • Increased participation in pediatric clinical trials.
  • Enhanced consistency in adverse event reporting for neonatal drug studies.
  • Optimization of operational efficiencies in pediatric drug research.

Conclusions:

  • The PTN has successfully developed and implemented strategies to improve pediatric drug trials.
  • Innovative methodologies are crucial for increasing efficiency and safety in pediatric research.
  • The PTN's work contributes to the safer use of drugs in children.

Keywords:
Adverse eventsOrganizational improvementsPediatric drug trials

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