Children should not be harmed by clinical trials, therefore should clinical trials be performed in children? We may need to temper this view as clinical trials provide the evidence we need to give children safe and effective medicines. Therefore it is unethical not to invite them to aid research? With the introduction of the new European legislation, EU Directive 2001/20/EC, in January 2007 we should see an increase in the number of clinical trials performed in children in Europe. The legislation provides both a legislative framework, to necessitate trials of medicines relevant to the childhood population, and a financial incentive for companies to perform them. This takes the form of a 6 month marketing authorisation extension. Similar legislative efforts within the USA have lead to an increase in the numbers of trials in children.
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