Advancing Pediatric Drug Development

What have we learnt from successful/failed pediatric oncology trials?

Community Member kudos icon + Community member
Briefly describe your research question :

Based on the pediatric oncology indications FDA has approved or rejected, what have we learnt from the successful/failed trials that might be useful for future trials (e.g. trial designs, endpoints, statistical methods)? In addition, with experience and knowledge accumulated in products approved for tissue agnostic indications, are there diseases (and drug classes) for which extrapolation (adults to adolescents, older to younger age group) would be considered appropriate for pediatric indication approvals? Should we explore more on the usefulness of biomarkers in pediatric oncology trials?




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Idea No. 167