I would like thank A. Gammelgaard and H. Bisgaard for their interest in my Editorial 1. They welcome the European Union initiative and rightly highlight that more than just money and infrastructure is needed to achieve successful clinical trials in children. As they say, ethical issues are paramount, relatively poorly studied in children and should be the subject of further work. There is also a paucity of data about how best to make trials work on a day-to-day basis, as recently discussed 2. Indeed, the surest way of making a paediatric trial a failure is to take an adult protocol, change the word “adult” to “child” throughout with the word processor and attempt to make the trial work. It will not.
It is to be hoped that all these very important paediatric clinical trial issues, ethical, organisational and practical, can be developed through the Seventh Framework Programme (FP7) for research, so that the needs and expectations of Europe's most vulnerable community, small children, can be addressed, leading to truly evidence-based therapeutics.
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