Ethical issues of clinical trials in children

Children should not be harmed by their participation in clinical trials, therefore should no clinical trials be performed? This is a view that needs to be balanced as clinical trials provide the evidence we need to allow children safe and effective prescribing of medicines. Therefore, is it unethical not to involve this population in research? The main push in the last decade has been to increase the number of medicines tested in the paediatric population. This culminated in the European Union ‘Paediatric Regulation’ in 2007 that meant that all new medicines, appropriate for use in children, must be researched in this population. The current challenge facing paediatricians involved in research is balancing harm, legislative requirements against the need for evidence based medicine. This review aims to debate some of the continuing ethical dilemmas, including practical considerations, faced by those involved with clinical trials in children.