How do pediatric numbers impact on trial design?
Biggest concern with numbers is treatment of na´ve children. Numbers for that cohort very limited. Only studies that could be done would be very small and focused
Numbers of treatment experienced children much greater. Certainly, not the numbers that could be recruited for an adult study but definitely sufficient for efficacy trials using virologic endpoints.
Pharmacokinetics, safety, antiviral activity could all be done for a range of age groups.