Clinical drug research in children: current international guidelines. Committee for Proprietary Medicinal Products

Drugs research in children entails a number of problems: medical-ethical, pharmacological (owing to the immaturity of the organs and the growth and development of the child) and financial (because children do not use many drugs). Consequently, children are exposed to insufficiently tested drugs and new therapeutic possibilities are withheld from them. Currently, little clinical drugs research in children is being carried out, but this is about to change. By now, European guidelines have been drawn up for the performance of clinical drugs trials according the 'good clinical practice' standards in children. In the Netherlands, a cooperative body has been set up (the Pediatric Pharmacology Network), which is to promote and coordinate paediatric pharmacological research in according with these guidelines.

Published by Nederlands tijdschrift voor geneeskunde, 1998. The guideline itself is at the source linked here.

pubmed.ncbi.nlm.nih.gov/9556981/