Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally
Earl Seltzer, MBA
Director, Global Feasibility-Site and Patient Access
Syneos Health, United States
Planning for pediatric trials requires a deep understanding of the regulatory, medical, and operational aspects of study conduct in order to ensure these trials are conducted as sufficient as possible. This session will include members of a CRO and developer space.
Learning Objective : Understand the ethical considerations and regulatory requirements when enrolling pediatric patients in research studies. Discuss pediatric extrapolation of efficacy from adult data and when it is appropriate.
Describe the level of evidence needed to initiate studies in the pediatric population, including instances when the disease is rare, and the condition does not occur in adults.
Initiation and Development of Pediatric Clinical Trials: Regulatory and Ethical Issues
Donna L. Snyder, MD
Pediatric Ethicist and Team Lead, Office of Pediatric Therapeutics, OC
FDA , United States
DIY Toy Box: Operational Considerations and Insights for Pediatric Clinical Trials
Gina Calarco, BSN, MPH
Associate Director, Pediatric Center of Excellence
IQVIA, United States