In recent years, the FDA has placed greater emphasis on the need for paediatric studies. As Shawn Patterson Baker and Jennifer Eastabrook of AXON Clinical Trial Services emphasise that clinical trials involving infants, children and/or adolescents require special consideration due to the developmental transitions that occur throughout this age range. Of particular concern when conducting a clinical trial with children is health literacy: a patient’s ability to comprehend and evaluate trial-related information in order to make an informed decision. The need for targeted, yet flexible, health literacy strategies is becoming evident.