12 - Specificities of safety management in paediatric psychopharmacological research

Abstract

This chapter addresses safety aspects in paediatric psychopharmacology researches. It provides overall perspective on the monitoring of safety and tolerability in clinical studies in children, along with more specific considerations on clinical trials within psychopharmacology. A lack or insufficient and underpowered clinical studies in children has been a well-recognised issue for decades, resulting in limited and inadequate safety information provided in product information/labelling. Over the last decades, there was a gradual shift in the overall clinical and regulatory landscape, with more paediatric studies being conducted and more efficacy and safety data generated in systematic manner. However, due to specificity and vulnerability of this population, there are still multiple challenges related to methodology to be applied to adequately address safety and tolerability aspects in clinical studies in children. The list is composed of but not limited to small sample size, slow recruitment rate, collection and assessment of safety data, and difficulties to detect safety issues in children, including long-term safety and effects on development and maturation.