Tutorial - Ethics of children in clinical trials
Children in trials - a European perspective
Discussion
Sammons notes that the EC has produced incentives for clinical research into childhood diseases and the importance of testing medicines specifically for children, on children, is well recognised. It seems the debate has moved from Edwards’ discussion of the justification of the inclusion of children in clinical trials to Sammons’ question as to whether it is unethical to not involve children in clinical trials.
Sammons outlines many of the arguments that this tutorial has covered and introduces some more detail about clinical trails with children. You might have noted:
- the widespread use of drugs with children which have not been tested on children
- identification of factors which affect consent, such as financial inducements or clincians’ influence
- children’s understanding in the assent process
In addition the article discusses trial design and shows some of the ways that it is possible to reduce the invasiveness of trial procedures on children. They make the important point that ‘pain, distress and fear’ should be minimised with children and this is linked to children’s inherent vulnerabilty.
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