Making Pediatric Trials a Feasible Reality: Extrapolating Data from Adult CKD Studies to Fulfil Considerable Unmet Needs in Pediatric Populations
Time: 3:00 pm
day: Pre-Conference Workshop Day
Details:
With significant prevalence of CKD in children, it is vital for drug developers to address this unmet medical need by conducting studies to gain regulatory approval in pediatric populations. Collaborate with regulators, pediatric nephrologists and industry sponsors to deliberate how to streamline feasibility of CKD trials in children, and discuss key considerations:
- How do drug developers make their CKD programs more available for the pediatric community?
- What must be demonstrated to meet regulatory requirements for potential approval of the drug in children with CKD? Extrapolation?
- How do we navigate considerations of ethical approval, informed consent, recruitment, and dosing when enrolling pediatrics into CKD trials?
- Exploring and contrasting traditional vs more innovative trial designs in the pediatric population
