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Pediatric Risk Assessment Map
Identifying and mitigating risks in pediatric clinical trials
Pediatric 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 Pediatric Risk Assessment Map is an interactive, reusable, and shareable tool that helps to identify common risks that exist in clinical trials that include pediatric patients and offers mitigation strategies for consideration.
ICON’s Centre for Pediatric Clinical Development formatted this guide in response to gaps in readily available tools focused on the pediatric population. It is intended to be the “first step” in risk identification and mitigation but can be used as a resource for pediatric included programmes at any stage.
What is it?
Interactive, reusable, shareable Excel tool:
- Identifies common risk in pediatric included trials
- Offers mitigation strategies for identified risks
- Tallies individual risks and areas of risk
Why did we create it?
Pediatric included trial success factors differ from adult trials
There are gaps in availability of tools to help identify and reduce risk in pediatric trial development
Who is it for?
Any stakeholder involved in the process of pediatric clinical trial design and management
When should it be used?
Anytime during trial development but recommended as early as possible
Pediatric Risk Assessment Map
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