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Paediatr Respir Rev. 2005 Mar;6(1):45-51.

Development of medicines for children in Europe: ethical implications.

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European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E144HB, UK.


Ethics of clinical trials in children have been a longstanding topic for debate. Children are vulnerable, unable to consent to participation in trials from a legal perspective and deserve to be protected. Ethical principles and the European legal framework define the safeguards that need to be put in place in any paediatric trial, be it performed in developed or in developing countries. It was considered that children should not be included in trials for ethical reasons. However, there is an ethical need to study medicines as data obtained in adults cannot be extrapolated to children. It is our collective responsibility to obtain sufficient information to be able to prescribe medicines safely whilst protecting children who are exposed in the trials. Future European paediatric regulations should encourage the development of medicines in high-quality ethical research and ensure availability of information to the public.

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