AI-Enabled Optimization of Early- Phase Clinical Trials Pilot Program; Request for Information

BullFrog AI, Inc. strongly supports the proposed pilot program for AI-enabled optimization of early-phase clinical trials. The company argues that integrating advanced AI technologies, such as automated data harmonization and causal inference, can significantly reduce development timelines, minimize patient risk, and improve regulatory decision-making.

Three academic researchers and industry experts (from Columbia University, Tulane University, and NouStarX LLC) support the FDA's pilot program for AI-enabled clinical trials. They argue that successful real-time clinical trials require a "Computational Evidence Infrastructure" that prioritizes data interoperability, human oversight, and continuous validation over just the implementation of AI technology.

Medrio, a software and services vendor for clinical trial technology, supports the FDA's pilot program for AI-enabled optimization of early-phase clinical trials. They advocate for including technology vendors as formal collaborators, establishing clear regulatory guardrails for data privacy and signal response, and ensuring that AI remains a tool to inform human clinical judgment rather than replace it.

McKesson Corporation supports the FDA's initiative to explore AI-enabled optimization of early-phase clinical trials and commends the agency's focus on addressing bottlenecks in the research ecosystem. The company recommends a risk-based governance framework, a focus on data quality, and the inclusion of operational feasibility and equity metrics in the pilot's evaluation.

Wave Life Sciences, a biotechnology company, supports the proposed AI-enabled optimization of early-phase clinical trials pilot program as a way to ensure the technology is thoughtfully controlled. They provide specific recommendations on trial scope, participant selection (particularly for smaller sponsors), infrastructure requirements like secure sandboxes, and safety oversight.

Humane Intelligence, a 501(c)(3) nonprofit organization, supports the FDA's pilot program for AI-enabled optimization of early-phase clinical trials as a necessary step toward modernizing clinical systems. They argue that the FDA should move beyond general AI risk frameworks to establish prescriptive, domain-specific evaluation criteria that ensure data integrity, algorithmic rigor, and equitable representation across diverse patient populations.

The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) supports the proposed pilot program and provides detailed recommendations on its design, metrics, and operational structure. They advocate for a multi-tiered approach to AI integration, emphasizing the need for clear validation, pre-competitive collaboration, and specific metrics to measure safety, efficiency, and model performance.

RTI International and Savana, a joint venture between a technology platform provider and a Contract Research Organization, submitted a formal response to the FDA's Request for Information. They provide detailed recommendations on pilot program design, including specific use cases for AI in oncology and rare disease trials, and advocate for a multi-stakeholder, pre-competitive collaboration model.

OncoLens, a healthcare technology company, supports the pilot program by providing specific recommendations on using AI to improve patient recruitment and site feasibility in early-phase oncology trials. They argue that AI can bridge the gap in trial access for community and rural settings by identifying eligible patients from unstructured clinical data and providing more accurate, data-driven site selection.

Catherine Cheung, a Clinical Development Operations Advisor at ActioPath Technologies, proposes that the pilot program evaluate AI as reusable, persistent infrastructure rather than standalone tools. The commenter argues that this approach can bridge accessibility gaps by expanding early-phase trial reach into community oncology practices and providing scalable operational support for emerging biotechnology sponsors.