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Special article: 2014 Pediatric Clinical Trials Forum
Clifford Bogue1, Linda A DiMeglio2, Samuel Maldonado3
1Department of Pediatrics, Yale School of Medicine, Yale-New Haven Children's Hospital, New Haven, Connecticut.
Pediatric Research
|December 10, 2015
Summary
A global Pediatric Clinical Trials Network is proposed to accelerate medical advances for children. This network aims to improve the safety and efficacy of pediatric drugs and devices, addressing critical gaps in research.
Area of Science:
- Pediatric Research
- Clinical Trials
- Medical Innovation
Background:
- Current clinical trial systems face challenges in testing and disseminating drugs and devices for pediatric populations.
- Inadequate pediatric indications for drugs and devices persist, especially in neonatology and rare diseases.
Purpose of the Study:
- To discuss the feasibility of establishing an independent global Pediatric Clinical Trials Network.
- To accelerate medical advances and improve the safety and efficacy of treatments for neonates, infants, children, adolescents, and young adults.
Main Methods:
- Convening key stakeholders, including the American Academy of Pediatrics, in November 2014.
- Identifying challenges within existing U.S. and global clinical trial systems for pediatric research.
- Developing a shared vision and Consensus Statement for a Global Pediatric Clinical Trials Network.
Main Results:
- Stakeholders mapped a vision for a network to enhance pediatric drug and device development.
- The proposed network would provide central infrastructure and support for pediatric subspecialties.
- Strong interest was expressed by participants in forming such a network to address unmet needs.
Conclusions:
- Attendees resolved to establish a Global Pediatric Clinical Trials Network.
- Commitment was made to engage in the creation and sustainment of the network.
- The network aims to facilitate the availability of innovative, high-quality pediatric therapies.
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