20 hours ago
Artificial Intelligence in Clinical Trials: Transforming Drug Development
In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota dives into the transformative role of artificial intelligence in clinical trials and drug development. Titled "Artificial Intelligence in Clinical Trials: Transforming Drug Development," Dr. Jagota discusses how AI is addressing critical challenges in clinical research, such as the high costs and lengthy timelines of traditional trials.
Dr. Jagota explores three key areas where AI is making an impact: patient selection and recruitment, real-time data monitoring, and adaptive trial designs. AI is revolutionizing patient matching, reducing trial costs, and improving data accuracy, while also enabling adaptive trials that can modify based on real-time results.
He also delves into the regulatory challenges of integrating AI, emphasizing the need for compliance with Good Clinical Practice (GCP) and maintaining data integrity. AI systems must be validated, and AI-driven changes must be documented carefully to meet regulatory standards.
Listeners will gain insights into emerging regulatory frameworks, including FDA guidelines and the concept of "regulatory-grade AI," ensuring AI's safe and ethical use in clinical trials.
Join Dr. Jagota as he examines how AI is reshaping clinical trials and the evolving regulatory landscape that supports this revolution.
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