Navigating Challenges in Pediatric Nephrology to Unveil a New Development Pathway
Time: 10:30 am
day: Pre-Conference Workshop B
Details:
Pediatric nephrology presents unique challenges in drug development and trial design. This workshop will explore the critical considerations for conducting clinical and preclinical trials in pediatric populations, focusing on ethical obligations, regulatory perspectives, and innovative approaches to trial design
This workshop will cover:
- Discuss studies of underlying disease mechanisms in pediatric nephrology and how insights into pathobiology translate into new diagnostic and therapeutic approaches to enhance understanding of disease drivers and inform treatment strategies
- Explore factors influencing trial design, including parental acceptance and concerns regarding participation, while highlighting ethical responsibilities to improve recruitment efforts
- Provide examples of successful trial designs that address pediatric-specific challenges, including dose finding and endpoint selection, applicable in both clinical and preclinical settings to equip you with practical strategies for designing effective pediatric trials
- Understand the importance of translating adult data for pediatric use and the challenges involved, including age-specific considerations in clinical and preclinical studies to facilitate the development of safe and effective treatments for children
- Review the FDA’s requirements for pediatric trials, including study protocols and conditions for data extrapolation, and their implications for clinical and preclinical trial design to ensure compliance and enhance the robustness of pediatric studies.
