Special article: 2014 Pediatric Clinical Trials Forum.

Published

Journal Article

In November 2014, the American Academy of Pediatrics convened key stakeholders to discuss the feasibility of accelerating children's medical advances by creating an independent global Pediatric Clinical Trials Network. The Forum identified challenges posed by the U.S. and global clinical trial systems regarding testing and disseminating drugs and devices for pediatric patients. Stakeholders mapped a vision to improve the safety and efficacy of pediatric drugs, biological products, and medical devices by creating a global Pediatric Clinical Trials Network. Such a Network would act as a central infrastructure for pediatric subspecialties and enable dedicated staff to provide clinical research sites with scientific, medical, and operational support. A Network would facilitate development and availability of innovative, high-quality therapies to extend and enhance the lives of neonates, infants, children, adolescents, and young adults. Participants expressed strong interest in forming such a Network, since drugs and devices still come to market without adequate pediatric indications-particularly in neonatology and rare diseases. Participants developed a Consensus Statement expressing their shared vision for a Network: Attendees of the Pediatric Clinical Trials Stakeholder Forum resolved to establish a Global Pediatric Clinical Trials Network and are committed to engage in the work to create and sustain it.

Full Text

Duke Authors

Cited Authors

  • Bogue, C; DiMeglio, LA; Maldonado, S; Portman, RJ; Smith, PB; Sullivan, JE; Thompson, C; Woo, H; Flinn, S

Published Date

  • April 2016

Published In

Volume / Issue

  • 79 / 4

Start / End Page

  • 662 - 669

PubMed ID

  • 26650344

Pubmed Central ID

  • 26650344

Electronic International Standard Serial Number (EISSN)

  • 1530-0447

Digital Object Identifier (DOI)

  • 10.1038/pr.2015.255

Language

  • eng

Conference Location

  • United States