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Pediatr Res. 2016 Apr;79(4):662-9. doi: 10.1038/pr.2015.255. Epub 2015 Dec 9.

Special article: 2014 Pediatric Clinical Trials Forum.

Author information

1
Department of Pediatrics, Yale School of Medicine, Yale-New Haven Children's Hospital, New Haven, Connecticut.
2
Department of Pediatrics, Indiana University School of Medicine, Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana.
3
Janssen Research & Development, Raritan, New Jersey.
4
Novartis Pharmaceuticals, East Hanover, New Jersey.
5
Department of Pediatrics, Duke University Medical Center, Durham, North Carolina.
6
Department of Pediatrics, University of Louisville, Louisville, Kentucky.
7
Pfizer Inc., New York, New York.
8
Department of Pediatrics, University of California Los Angeles, Los Angeles, California.
9
Susan Flinn Associates, Washington, District of Columbia.

Abstract

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.

PMID:
26650344
DOI:
10.1038/pr.2015.255
[Indexed for MEDLINE]

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