Comment from argenx
AnonymousSupportBusiness
Summary: argenx, a global immunology company, supports the proposed AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program and provides specific recommendations for its implementation. They advocate for including non-US study sites to ensure representative data, establishing a data-quality monitoring layer to manage signal uncertainty, and clarifying the inclusion of Phase 4 or Phase 2b open-label studies.
Re: Docket No. and Title of Guidance FDA Docket FDA-2026-N-4390
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information
argenx, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, appreciates the opportunity to comment on FDA’s request for information regarding the proposed AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program.