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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
[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
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- Prematurely terminated or negative trial results often remain unpublished, leading to research inefficiencies and potential safety concerns.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.
Abstract:
Clinical trials have a fundamental role in promoting an evidence based use of drugs in adults and in children. However, it is often difficult to identify the few paediatric studies carried out and to thus implement knowledge derived from them. Furthermore, studies that are stopped prematurely or that have insignificant or negative results often remain unpublished, leading to duplication of effort by researchers, waste of resources and concealment of potentially toxic risks. The European Community decided to support the development of a European register of clinical trials in children as part of the Fifth Framework Thematic Programme "Quality of Life" in 2002. The project DEC-net is coordinated by the Laboratory of Mother and Child Health of the Mario Negri Institute for Pharmaceutical Research in Milan and currently involves members of four countries; France, Italy, Spain and the United Kingdom. It is unique in that it is the first population oriented clinical trial register. Such a register represents a useful source for planning new studies, promoting communications and collaborations between researchers, facilitating patient access and recruitment into trials, preventing trial duplication and inappropriate funding and identifying the therapeutic needs of children that remain neglected. It will also allow for active monitoring of new or evolved knowledge of drug therapies.
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