The Pharmaceutical Journal
Vol 280 No 7490 p205
23 February 2008

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EC advises on ethical considerations of paediatric trials

Final guidance on carrying out clinical trials involving children has been published by the European Commission.
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The guidance has been drawn up specifically for paediatric trials because of the general acceptance that children cannot be treated as though they are small adults.

It warns that, in general, minors are unable to give legally valid consent to participation in trials, but that their assent should be sought using age-appropriate information. This lack of legal ability to consent has implications on the design, analysis and the choice of comparators used in trials, it goes on, advising that such trials should only be performed by trained investigators with paediatric experience.

Pain, fear, distress and parental separation should be prevented or minimised when unavoidable.

Neonates, it adds, are the most vulnerable of all paediatric age groups and require even more careful review.

The guidance also makes the point that research ethics committees need to include paediatric expertise in order to balance the benefits and risks of research in children.