Background and aims On 2 April 2014 the European Parliament adopted the European Clinical Trials Regulation that replaces the European Clinical Trials Directive of 2001. This paves the way for greater harmonisation of European paediatric research along with setting new rules for engaging clinical trials with vulnerable populations, including children.
Methods This paper examines key points in the European Clinical Trial Regulation that will affect the paediatric community in developing new medicines for children as well as impact nearly all areas of European paediatric research.
The following important developments are explained:
· the distinction between a ‘clinical trial’ and a ‘clinical study’,
· the new requirements for registering clinical trials on publicly accessible databases,
· requirements to report clinical trials,
· new definitions of ‘vulnerable populations’ and how this impacts paediatric research,
· informed consent rules,
· requirements for ethical review and their potential impact at national and institutions levels, and
· the requirements for publishing the results of clinical trials.
Results The intended result of the EU Clinical Trial Regulation is to improve the environment for clinical research in Europe. It is also intended to provide greater protections to research subjects while improving the environment for academic research.
Conclusions Important hurdles that arose in the context of the previous Clinical Trials Directive have been addressed. New challenges, however, will arise that affect both the ability to organise clinical trials among paediatric research centres as well as financial implications for those leading paediatric research.