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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.1 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.2
Differences in pharmacokinetics and pharmacodynamics, and adverse reactions, are common in children compared to adults. Growth and maturation processes, as well as certain specific diseases, are unique to children.3 However, it is rare that a phase I study takes place in children. Phase I trials are the first stage of testing in …
Competing interests Helen Sammons is a member of the Ethics Advisory Board for the TINN (Treat Infection in Neonates) Project.
Provenance and peer review Commissioned; internally peer reviewed.