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.

PRAM Risk Map

What is it?

Interactive, reusable, shareable Excel tool:

  • Identifies common risk in paediatric included trials
  • Offers mitigation strategies for identified risks
  • Tallies individual risks and areas of risk

Why did we create it?

Paediatric included trial success factors differ from adult trials

There are gaps in availability of tools to help identify and reduce risk in paediatric trial development

Who is it for?

Any stakeholder involved in the process of paediatric clinical trial design and management

When should it be used?

Anytime during trial development but recommended as early as possible

Paediatric Risk Assessment Map