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NIHR Medicines for Children Research Network: improving children's health through clinical research
Andrew C Rose1, William Van't Hoff, Michael W Beresford
1NIHR Medicines for Children Research Network (MCRN), Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Alder Hey Children's NHS Foundation Trust, Liverpool L12 2AP, UK.
Insights
Unlicensed medicine use in children necessitates evaluation. The EU Paediatric Regulation and the National Institute of Health Research (NIHR) Medicines for Children Research Network (MCRN) in England aim to improve pediatric medicine research and collaboration across Europe for better children
Area of Science:
- Pediatric Pharmacology
- Medicinal Research
- Regulatory Science
Background:
- Pervasive use of unlicensed medicines in pediatric populations highlights a critical need for evidence-based evaluation.
- The European Union (EU) Paediatric Regulation was enacted to address these concerns regarding pediatric medicine use.
- The National Institute of Health Research (NIHR) Medicines for Children Research Network (MCRN) was established in England to support pediatric medicine research.
Purpose of the Study:
- To outline the establishment and function of the NIHR Medicines for Children Research Network (MCRN) in England.
- To describe the role of MCRN within the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA).
- To emphasize the collaborative efforts to improve the conduct of research for the benefit of children's health.
Main Methods:
- The establishment of the MCRN was a direct outcome of the EU Paediatric Regulation.
- MCRN provides support for public and industry-sponsored studies, including feasibility, site setup, and patient recruitment.
- MCRN actively participates in Enpr-EMA, fostering European-wide research coordination and collaboration.
Main Results:
- The MCRN supports a range of pediatric medicine research activities.
- Collaboration through Enpr-EMA facilitates a coordinated approach to pediatric research across Europe.
- MCRN's engagement with industry and other networks enhances research conduct.
Conclusions:
- The MCRN plays a vital role in addressing the need for evaluated medicines in children.
- European collaboration through Enpr-EMA is crucial for advancing pediatric medicine research.
- Improved research conduct, supported by networks like MCRN, directly benefits children's health outcomes.
Abstract:
The need to evaluate medicines for children is widely acknowledged due to pervasive unlicensed medicine use in the pediatric setting. The EU Paediatric Regulation was developed to address these considerations, which subsequently led to the establishment of the National Institute of Health Research (NIHR) Medicines for Children Research Network (MCRN) in England. MCRN supports public and industry studies, and facilitates feasibility, site setup, recruitment and other services. The MCRN and other networks are members of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA). Enpr-EMA was established to foster and coordinate research, and develop collaborations across Europe. MCRN works with Enpr-EMA, industry and others to improve the conduct of research for the benefit of children's health.
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