Navigating Disclosure Complexity: The Power Of Human-Centered AI

Every regulatory professional navigating today’s AI-driven trial landscape needs the tools, frameworks, and real-world insights to stay ahead of shifting expectations and lead with confidence. Artificial intelligence is rapidly reshaping clinical trial operations, and the implications are impossible to ignore. From evolving global disclosure requirements to heightened expectations for participant-friendly communication, the stakes around transparency and compliance are higher than ever. Yet, with inconsistent outputs from major tech vendors and the very real risk of “hallucinations” from large language models, sponsors face new layers of complexity that can erode trust.

This presentation provides clarity for regulatory leaders by drawing on Citeline’s deep experience. Brian Kuzich and Jack Marks explore how AI is transforming disclosure practices, the persistent hurdles sponsors must overcome, and how a carefully designed human-in-the-loop approach can balance innovation with accountability.