Overview:
Clinical development processes for pediatric trials differ from adult trials. These differences, and measures to reduce associated risks, may be difficult to identify, especially when resources are constrained.
The Pediatric Risk Assessment Map (PRAM) is an interactive, reusable and shareable tool designed by ICON’s Centre for Pediatric Clinical Development (CPCD). This guide was developed 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 programs at any stage.
This webinar will explore how to use PRAM to confirm, quantify and assess the impact of identified potential risks unique to clinical trials with pediatric participants.
What you’ll learn:
- Challenges and critical success factors in developing pediatric clinical trials
- Impacts of trial design and value proposition to participants and their families
- Applicable mitigation strategies for potential risks
Who should attend:
This webinar is aimed at professionals with an interest in pediatric research including those working in the following areas:
- Research and development
- Clinical research
- Medical affairs
- Scientific affairs
- Regulatory affairs
- Clinical affairs
- Project management
- Clinical operations
- Risk management
- Executives
- Health care professionals
- Patient advocacy groups and their members
- Anyone with an interest in the future of pediatric research
Speakers:
Heather Peterson, RN, BSN
Ms Peterson has a diverse background in clinical research, both as a registered nurse (RN) and in clinical operations. She applies her expertise in pediatric populations to assist in strategic review of protocol development, ensuring critical pediatric content is thoughtfully measured and consistent with governing bodies while incorporating patient-family centric considerations. She previously served as the lead clinical research coordinator at Renown Regional Medical Center, a non-profit hospital in Reno, Nevada, where she coordinated and managed clinical trials of varied phases and indications. She worked across several therapeutic specialties to streamline scientific review committees and institutional review boards (IRB) submission processes. She brings a site and patient perspective that is valuable in developmental aspects of patient recruitment, enrollment, and retention.