Registration of Trials in Children. Update of Current International Initiatives.

Abstract

The last few years have been characterized by an increasing awareness of the inadequacy of children’s therapeutic options and of science’s insufficient knowledge in the area. The well-documented, frequent use of off-label and unlicensed medications in the young, with the increased risks it carries, can be seen as an indicator of the still limited knowledge on paediatric drug therapies. This lack of data is generally due to the greater difficulties inherent (ethical, practical, and economic) in carrying out clinical trials in children. In such a context, given the scant evidence available on safety and efficacy of drug therapies, the use of drugs in children is often inappropriate (not rational).