Pediatric Clinical Trials
Considerations for Enrollment and Retention
Pediatric clinical trials require careful consideration due to the physiological differences between children and adults. Many elements of traditional clinical research trial design and patient communications must be adjusted to accommodate these differences and special attention must be paid to the safety of children, their growth and development, and the overall experience of patients and caregivers.
In this insightful paper we explore regulatory guidelines implemented to encourage pediatric drug development, specific study considerations particularly concerning safety and regulatory aspects (e.g., obtaining informed consent for adolescents), adapting endpoints, and the role of parents/caregivers and patient advocacy groups in patient recruitment and retention and throughout study lifespan.
Explore the nuanced approaches necessary for successful pediatric drug development.
