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.
You may also be interested in...
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.
When it becomes effective in the EU in May, the new General Data Protection Regulation will have major implications for the planning and conduct of clinical trials and research. Lawyers David Pountney and Richard Binns discuss how pharmaceutical companies and CROs should plan to ensure they remain compliant.