Paediatric trials differ from adult studies in the clinical development process and these differences, as well as the measures needed to reduce risk, may be challenging to identify.
The Paediatric Risk Assessment Map is an interactive, reusable, and shareable tool that helps to identify common risks that exist in clinical trials that include paediatric patients and offers mitigation strategies for consideration.
ICON’s Centre for Paediatric Clinical Development formatted this guide in response to gaps in readily available tools focused on the paediatric population. It is intended to be the “first step” in risk identification and mitigation but can be used as a resource for paediatric included programmes at any stage.