Risk-proportionate approach to Paediatric Clinical Trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation has been published by Clinical Trials


Paediatric Clinical Trials support the development of medicines for children. The change in the paediatric research environment has led to the recognition of the importance for investigator-initiated clinical trials in furthering medical knowledge to guide paediatric prescribing practices. However, the ‘one-size-fit-all’ approach in implementing the European Clinical Trials Directive has been identified as a barrier and is placing disproportionate burden to the conduct of ‘low-risk’ paediatric clinical trials. This article discusses the current challenges in drug product labelling and management under the current Directive to introduce the requirements of the forthcoming European Clinical Trials Regulation.


Two European Multinational Paediatric Clinical Trials funded by the c4c project are presented to provide a comparative insight into current practical challenges and to illustrate how the new Regulation is set to implement a risk-proportionate approach to facilitate more efficient trial delivery. The European Clinical Trials Regulation gives a strong push for a risk-proportionate approach and offers a path for more efficient delivery of investigator-initiated paediatric clinical trials.


You can read the full article here.