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German Paediatric Research Network (PAED-Net)

Monika Seibert-Grafe1, Raunhild Butzer, Fred Zepp

  • 1Interdisciplinary Centre for Clinical Trials (IZKS), University Medical Centre Mainz, Mainz, Germany. seibert-grafe@izks-mainz.de

Paediatric Drugs
|January 9, 2009
PubMed

Insights

Pediatric clinical trials are essential for advancing child healthcare. The German Paediatric Network (PAED-Net) has significantly improved pediatric trial conduct and awareness through infrastructure development and training.

Area of Science:

  • Pediatric clinical pharmacology
  • Drug development in children
  • Evidence-based medicine for pediatrics

Background:

  • Clinical trials in children are mandatory for drug safety and efficacy, especially for off-label use.
  • The European Union's Paediatric Regulation (2007) mandates pediatric clinical trials.
  • The German Paediatric Network (PAED-Net) was founded in 2002 to enhance pediatric clinical trials.

Purpose of the Study:

  • To establish competence, infrastructure, networking, and education for pediatric clinical trials in Germany.
  • To improve the quality and conduct of clinical trials involving children.
  • To raise awareness among medical professionals and the public about the importance of pediatric trials.

Main Methods:

  • Establishment of a network comprising six pediatric clinical units and a coordinating office.
  • Development and implementation of training programs for investigators and nurses.
  • Securing public funding from the German Ministry of Education and Research.

Main Results:

  • Significant improvements in the conduct of pediatric clinical trials have been achieved.
  • Enhanced knowledge and awareness regarding pediatric clinical trials among healthcare professionals and the public.
  • Strengthened infrastructure and networking capabilities for pediatric research.

Conclusions:

  • Quality-controlled data from pediatric trials are crucial for therapeutic innovation and evidence-based medicine in children.
  • Despite challenges, pediatric trials are vital for ensuring the youngest patient population benefits from medical advancements.
  • PAED-Net has successfully contributed to advancing pediatric clinical research in Germany.

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