The pace at which new treatments are introduced to paediatric practice is determined, in part, by our willingness and ability to conduct clinical trials in children. In the absence of such studies, the introduction of modified adult treatments resulted in some unpredictable and serious consequences.1

In 2014, guidance on clinical research in infants, children and young people was published by the Royal College of Paediatrics and Child Health (RCPCH).2 The RCPCH clearly states its support for research ‘that has the objectives of understanding, preventing and treating disease and preserving health’, recognising children's rights to have their care ‘assured by research’. Alongside these principles, there is a requirement that children participating in research studies should, ideally, be exposed to no greater than ‘minimal or low’ risk, together with an emphasis on the importance of obtaining the views of affected children and families on protocol …