Pediatric Cancer Dataset Gaps, FDA ‘High Bar’ Make Use Of External Control Arms Difficult
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.
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With more than 1,600 pediatric and related clinical trials in house, the agency wants ideas for how they can be analyzed to advance pediatric drug development.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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.