Special article

2014 pediatric clinical trials forum

Clifford Bogue, Linda DiMeglio, Samuel Maldonado, Ronald J. Portman, P. Brian Smith, Janice E. Sullivan, Charles Thompson, Heide Woo, Susan Flinn

Research output: Contribution to journalArticle

6 Citations (Scopus)

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 US 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.

Original languageEnglish (US)
Pages (from-to)662-669
Number of pages8
JournalPediatric Research
Volume79
Issue number4
DOIs
StatePublished - Apr 1 2016

Fingerprint

Clinical Trials
Pediatrics
Equipment and Supplies
Pharmaceutical Preparations
Neonatology
Rare Diseases
Biological Products
Young Adult
Consensus
Newborn Infant
Safety
Research

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Bogue, C., DiMeglio, L., Maldonado, S., Portman, R. J., Smith, P. B., Sullivan, J. E., ... Flinn, S. (2016). Special article: 2014 pediatric clinical trials forum. Pediatric Research, 79(4), 662-669. https://doi.org/10.1038/pr.2015.255

Special article : 2014 pediatric clinical trials forum. / Bogue, Clifford; DiMeglio, Linda; Maldonado, Samuel; Portman, Ronald J.; Smith, P. Brian; Sullivan, Janice E.; Thompson, Charles; Woo, Heide; Flinn, Susan.

In: Pediatric Research, Vol. 79, No. 4, 01.04.2016, p. 662-669.

Research output: Contribution to journalArticle

Bogue, C, DiMeglio, L, Maldonado, S, Portman, RJ, Smith, PB, Sullivan, JE, Thompson, C, Woo, H & Flinn, S 2016, 'Special article: 2014 pediatric clinical trials forum', Pediatric Research, vol. 79, no. 4, pp. 662-669. https://doi.org/10.1038/pr.2015.255
Bogue C, DiMeglio L, Maldonado S, Portman RJ, Smith PB, Sullivan JE et al. Special article: 2014 pediatric clinical trials forum. Pediatric Research. 2016 Apr 1;79(4):662-669. https://doi.org/10.1038/pr.2015.255
Bogue, Clifford ; DiMeglio, Linda ; Maldonado, Samuel ; Portman, Ronald J. ; Smith, P. Brian ; Sullivan, Janice E. ; Thompson, Charles ; Woo, Heide ; Flinn, Susan. / Special article : 2014 pediatric clinical trials forum. In: Pediatric Research. 2016 ; Vol. 79, No. 4. pp. 662-669.
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