Pediatric Oncology Subcommittee
Oncologic Drugs Advisory Committee
October 17, 2002
Questions to the Committee
Should adult safety studies precede the initiation of pediatric oncology clinical studies?
Should demonstration of activity in any adult tumor precede pediatric oncology clinical studies?
Should activity in similar or related tumors in adults precede pediatric oncology clinical studies?
On what basis can pediatric oncology clinical studies proceed studies if no activity is shown in adult studies?
What would the ideal situation be?
Potential development plans for new cancer therapies could include combined adult and pediatric studies, separate but simultaneous adult and pediatric studies with continuous information sharing, sequential adult and pediatric studies with information sharing, or completely independent programs.
What are the potential advantages and drawbacks of coordinating adult and pediatric early clinical development?
What should the FDA adopt as a general recommendation regarding the timing of the initiation of pediatric oncology clinical studies in a drug development program?