[A complete clinical trial register is already a reality in the paediatric field]

Evelyne Jacqz-Aigrain1, Sétareh Zarrabian, Chiara Pandolfini

  • 1Hôpital Robert Debré, Paris, France. evelyne.jacqz-aigrain@rdb.aphp.fr

Therapie
|August 5, 2006
PubMed

Insights

A new European register of pediatric clinical trials was established to improve drug use in children. This initiative aims to enhance data accessibility, prevent research duplication, and identify unmet therapeutic needs in pediatric populations.

Area of Science:

  • Clinical Pharmacology
  • Pediatric Research
  • Health Informatics

Context:

  • Evidence-based drug use in children is hindered by the difficulty in identifying and accessing pediatric clinical trial data.
  • Prematurely terminated or negative trial results often remain unpublished, leading to research inefficiencies and potential safety concerns.
  • The European Community initiated the development of a European register for pediatric clinical trials in 2002.

Purpose:

  • To establish a population-oriented clinical trial register specifically for children.
  • To address the challenges of identifying, implementing, and disseminating pediatric clinical trial knowledge.
  • To create a centralized resource for pediatric clinical trial information.

Summary:

  • The DEC-net project, coordinated by the Mario Negri Institute, established a unique, population-oriented European register of clinical trials in children.
  • This register involves researchers from France, Italy, Spain, and the United Kingdom.
  • It serves as a crucial tool for planning studies, fostering collaboration, and improving patient access to trials.

Impact:

  • Facilitates the planning and execution of new pediatric clinical studies.
  • Promotes communication and collaboration among researchers in pediatric drug development.
  • Enhances patient access and recruitment for pediatric clinical trials, preventing duplication and optimizing funding.
  • Identifies neglected therapeutic needs in children and enables active monitoring of drug therapy knowledge.

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