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Is There an Urgent need for Global Alignment on External Controls in Clinical Trials?
Session Chair(s)
Gracy G Crane, PHD, MS
Policy Lead
Roche, United Kingdom
This session will focus on use of external controls, including historical cohorts and real-world data, in clinical trials across drug development, focusing on the gaps and need for alignment between regulators from different regions
Learning Objective : Review and compare the current guidance and reflection papers on external controls from leading regulatory agencies, including the FDA, PMDA, and the MHRA, including discussing progress in the EU On this topic; Analyze the key similarities and differences in their recommendations concerning study design, and the need for some level of alignment.
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