AI & ML in Clinical Trials explores how artificial intelligence and machine learning are reshaping the design, execution, and oversight of clinical trials across the life sciences industry. The episode examines how these technologies are being used to improve protocol design, patient recruitment, site selection, data monitoring, and trial efficiency, helping organizations reduce timelines and make more informed decisions throughout the clinical development process.
The discussion also addresses the regulatory and quality considerations that come with adopting AI and ML in a highly regulated environment. Topics include data integrity, algorithm transparency, validation expectations, and FDA oversight as these tools become more embedded in clinical operations. Rather than focusing on hype, this episode emphasizes responsible implementation and what sponsors need to consider to leverage AI and ML while maintaining compliance, patient safety, and regulatory confidence.
