Literature DB >> 26650344

Special article: 2014 Pediatric Clinical Trials Forum.

Clifford Bogue1, Linda A DiMeglio2, Samuel Maldonado3, Ronald J Portman4, P Brian Smith5, Janice E Sullivan6, Charles Thompson7, Heide Woo8, Susan Flinn9.   

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.

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Year:  2015        PMID: 26650344     DOI: 10.1038/pr.2015.255

Source DB:  PubMed          Journal:  Pediatr Res        ISSN: 0031-3998            Impact factor:   3.756


  1 in total

Review 1.  Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety.

Authors:  Laura Cuzzolin; Alessandra Atzei; Vassilios Fanos
Journal:  Expert Opin Drug Saf       Date:  2006-09       Impact factor: 4.250

  1 in total
  8 in total

1.  The future of pediatric research: European perspective.

Authors:  Eleanor J Molloy; Neena Modi; Anne Greenough; Hugo Lagercrantz; Cynthia F Bearer; Mark Turner
Journal:  Pediatr Res       Date:  2016-11-04       Impact factor: 3.756

Review 2.  Moving toward a paradigm shift in the regulatory requirements for pediatric medicines.

Authors:  William Wei Lim Chin; Angelika Joos
Journal:  Eur J Pediatr       Date:  2016-09-19       Impact factor: 3.183

3.  The Need for Pediatric Drug Development.

Authors:  Robert M Ward; Daniel K Benjamin; Jonathan M Davis; Richard L Gorman; Ralph Kauffman; Gregory L Kearns; Mary Dianne Murphy; Catherine M T Sherwin
Journal:  J Pediatr       Date:  2017-09-21       Impact factor: 4.406

4.  Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018.

Authors:  Irin Tanaudommongkon; Shogo John Miyagi; Dionna J Green; Janelle M Burnham; John N van den Anker; Kyunghun Park; Johanna Wu; Susan K McCune; Lynne Yao; Gilbert J Burckart
Journal:  Clin Pharmacol Ther       Date:  2020-06-22       Impact factor: 6.875

5.  IDeA States Pediatric Clinical Trials Network for Underserved and Rural Communities.

Authors:  Robert D Annett; Sheva Chervinskiy; Thomas H Chun; Kelly Cowan; Kristina Foster; Nathaniel Goodrich; Matthew Hirschfeld; Daniel S Hsia; J Dean Jarvis; Kurtis Kulbeth; Christi Madden; Clare Nesmith; Hengameh Raissy; Judith Ross; J Philip Saul; Bruce Shiramizu; Paul Smith; Janice E Sullivan; Lauren Tucker; Andrew M Atz
Journal:  Pediatrics       Date:  2020-09-17       Impact factor: 7.124

Review 6.  Developmental Pharmacodynamics and Modeling in Pediatric Drug Development.

Authors:  Laurie S Conklin; Eric P Hoffman; John van den Anker
Journal:  J Clin Pharmacol       Date:  2019-09       Impact factor: 3.126

Review 7.  The Challenges of Pediatric Drug Development.

Authors:  Klaus Rose
Journal:  Curr Ther Res Clin Exp       Date:  2019-01-26

Review 8.  European research networks to facilitate drug research in children.

Authors:  Mark A Turner; Katharine Cheng; Saskia de Wildt; Heidrun Hildebrand; Sabah Attar; Paolo Rossi; Donato Bonifazi; Adriana Ceci; Joana Claverol; Begonya Nafria; Carlo Giaquinto
Journal:  Br J Clin Pharmacol       Date:  2020-09-20       Impact factor: 3.716

  8 in total

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