title: Special article: 2014 Pediatric Clinical Trials Forum.
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.
authors.affiliation: Department of Pediatrics, Yale School of Medicine, Yale-New Haven Children's Hospital, New Haven, Connecticut.
authors.forename: Clifford
authors.initials: C
authors.lastname: Bogue
authors.affiliation: Department of Pediatrics, Indiana University School of Medicine, Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana.
authors.forename: Linda A
authors.initials: LA
authors.lastname: DiMeglio
authors.affiliation: Janssen Research & Development, Raritan, New Jersey.
authors.forename: Samuel
authors.initials: S
authors.lastname: Maldonado
authors.affiliation: Novartis Pharmaceuticals, East Hanover, New Jersey.
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Portman
authors.affiliation: Department of Pediatrics, Duke University Medical Center, Durham, North Carolina.
authors.forename: P Brian
authors.initials: PB
authors.lastname: Smith
authors.affiliation: Department of Pediatrics, University of Louisville, Louisville, Kentucky.
authors.forename: Janice E
authors.identifier: http://orcid.org/0000-0003-1682-1607
authors.initials: JE
authors.lastname: Sullivan
authors.affiliation: Pfizer Inc., New York, New York.
authors.forename: Charles
authors.initials: C
authors.lastname: Thompson
authors.affiliation: Department of Pediatrics, University of California Los Angeles, Los Angeles, California.
authors.forename: Heide
authors.initials: H
authors.lastname: Woo
authors.affiliation: Susan Flinn Associates, Washington, District of Columbia.
authors.forename: Susan
authors.initials: S
authors.lastname: Flinn
mesh_terms: D000293:Adolescent; D002648:Child; D002986:Clinical Trials as Topic; D006801:Humans; D010372:Pediatrics; D014481:United States