FDA Launches Pilot Program to Optimize Early-Phase Clinical Trials with AI

The U.S. Food and Drug Administration (FDA) is initiating a pilot program to explore how AI-enabled technologies can improve the efficiency, speed, and quality of decision-making in early-phase clinical trials. This program aims to enhance patient recruitment, optimize dose escalation, and improve safety monitoring. It seeks to facilitate more informed go/no-go decisions while maintaining rigorous scientific and regulatory standards.