FDA on AI and ML in Clinical Trials at the SCOPE Summit 2024

In a significant move towards embracing the future of medical research, the US Food and Drug Administration (FDA) is making strides in integrating artificial intelligence (AI) and machine learning (ML) into the realm of clinical trials and drug development.

At the SCOPE Summit 2024, an event that has become a pivotal meeting ground for experts in clinical trial strategy and operations, FDA representatives delved into the agency’s current stance and future plans regarding these cutting-edge technologies.

During a fireside chat at the Summit held in Orlando, Marsha Samson from the CDER (Center for Drug Evaluation and Research) office, which has a special focus on AI and ML, addressed the hesitancy among trial sponsors in incorporating AI into their processes.

Many sponsors have expressed concerns about how the FDA might perceive the use of such technologies. Samson emphasized the FDA’s openness to AI and ML, noting that the agency has established contact lines specifically for trial sponsors to discuss their AI-based methodologies and ensure they align with regulatory compliance.

The FDA’s proactive approach towards AI and ML was further highlighted in May 2023 when the agency released comprehensive guidance on the use of these technologies in drug development.

Following this, a discussion paper was published, which has since garnered over 600 comments, indicating a high level of engagement from the industry.

This engagement is a testament to the growing interest and application of AI in drug development, as evidenced by the increasing number of submissions to the FDA that leverage AI technologies.

The implications of integrating AI into drug development are profound. Kevin Bugin, the deputy director of operations for CDER, pointed out the accelerated pace of drug development in recent years, partly fueled by advancements in technology. These innovations are not just improving the treatment of symptoms but are paving the way for tackling diseases at their core.

The FDA’s efforts to facilitate the use of AI and ML in clinical trials and drug development mark a significant shift towards more efficient, innovative, and potentially transformative approaches to medical research. As the regulatory landscape evolves to accommodate these technologies, the future of drug development and patient care looks increasingly promising.

This development was reported by Clinical Trials Arena, shedding light on the FDA’s role in fostering innovation within the pharmaceutical industry.