Regulators, sponsors and technology providers are exploring new ways to improve trial efficiency, data quality and decision-making. One emerging area is real-time clinical trial monitoring, where trial data may be reviewed and analyzed more continuously rather than only at traditional milestones.
This shift is gaining attention following the FDA’s pilot involving real-time review of clinical trial data from AstraZeneca and Amgen studies. It also reflects broader interest in AI-enabled tools that could improve the speed and quality of clinical development decisions. While these approaches could help identify issues earlier and support faster regulatory review, questions remain around implementation, data standards, site burden and how widely real-time models can be applied.
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