Avoiding clinical trials in children.

摘要

Clinical trials of medicines in children are essential. So it may seem strange, despite recent lobbying and legislation, to discuss when clinical trials in children can be avoided. One specific aim of the Paediatric Regulation was that it should improve the health of children in Europe without subjecting children to unnecessary trials. A clinical trial in children should only take place when the information cannot be gained from a trial in the adult population. This should always be kept in mind when planning a protocol. Can the information be reliably obtained from adults? The article by Mulla et al in this month's Drug therapy is a good example of how this can be put into practice and clinical trials in children avoided.