Better medicines for the paediatric population via a Dutch paediatric trial network.
- Increase quality of paediatric healthcare by research
- Support sponsors and research sites in excecuting clinical trials to enhance quality
- Connect within The Netherlands and abroad to facilitate conduct of paediatric clinical trials
There is a large gap in the availability of thoroughly studied and licensed diagnostic or therapeutic means for children as compared to adults. Only a small percentage of drugs and devices approved by the European Medicines Agency (EMA) or the Food and Drug Administration (FDA) are labelled for paediatric use. Moreover, only 30% of marketed drugs in Europe include a Paediatric authorization and less than 50% of authorized medicines commonly used in children have been properly tested in Paediatric populations. This resulted in a lack of suitable, authorized medicinal products to treat conditions in children and left healthcare with no alternative but to use off-label products and unauthorized products with the associated risks of inefficacy or adverse reactions. As a result, Paediatric patients are often exposed to a rate of potentially dangerous medication errors three times higher than that for adult
As such, children should be protected from inappropriate use of medical treatments. This protection could be achieved by conducting more well-designed Paediatric clinical trials and expanding participation of children in these clinical trials in order to increase the number of labelled drugs for Paediatric use.