Patient-Reported Outcomes In Pediatric Cancer Trials Endorsed By US FDA Advisory Committee
Incorporation of the Ped-PRO-CTCAE instrument would help inform short-term tolerability and long-term effects of treatment, particularly newer immunotherapy agents, but there are logistical and operational challenges to overcome, advisory committee members said.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
European data privacy regulations could further complicate efforts to build external control arms using real-world data that are housed outside the US, experts said at advisory committee meeting on use of real-world evidence in pediatric cancer drug development.