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

Panoptive, a clinical trial oversight technology company, supports the FDA's pilot program for AI-enabled clinical trials. They argue that the pilot should focus on the "full oversight loop"—measuring how AI-surfaced signals are converted into accountable human decisions and inspection-ready records—rather than just signal detection speed. They provide specific recommendations on metrics, participant selection, and the need for human-in-the-loop governance to ensure reliability and regulatory compliance.

Rubrum Advising, a healthcare consulting firm, supports the FDA's pilot program for AI-enabled optimization of early-phase clinical trials. They specifically recommend expanding the program's scope to include a separate pilot for medical device early feasibility studies (EFS) to better leverage AI for iterative device development and safety monitoring.

Anthropic, an AI safety and research company, supports the FDA's pilot program but recommends a framework that distinguishes between the obligations of the AI tool sponsor and the developer of the underlying general-purpose model. They argue for architecture-neutral technology selection, structured provenance documentation for training data, and a managed lifecycle for model versioning rather than a general requirement to freeze model versions during a trial.

UT MD Anderson Cancer Center supports the proposed pilot program and suggests expanding its scope to include radiopharmaceuticals, which they offer to help pilot. They also recommend that the FDA require centralized radiotherapy quality assurance and standardized nomenclature to ensure the scientific integrity and reliability of AI-enabled analyses in combination trials.

Rubrum Advising, a healthcare consulting firm, supports the FDA's pilot program for AI-enabled optimization of early-phase clinical trials. They specifically recommend expanding the program's scope to include a separate pilot for medical device early feasibility studies (EFS) to better leverage AI for iterative device development and safety monitoring.

Noetik, an AI-native oncology company, supports the FDA's pilot program for using AI to optimize early-phase clinical trials. They recommend prioritizing oncology trials, establishing a coordinated regulatory engagement track, and ensuring the pilot includes a significant share of slots for small and mid-size AI-native sponsors.

CIMS Global is submitting a high-level overview of its capabilities and ready-to-implement solutions regarding AI-enabled optimization in early-phase clinical trials. They express support for the FDA's initiative and offer to provide additional technical materials to help advance clinical trial innovation.

Wicked Problem Wizards, an advisory firm focused on clinical trial data quality, supports the pilot program but emphasizes that it requires robust Risk-Based Quality Management (RBQM) and pre-competitive cross-industry collaboration to be successful. They argue that the FDA should act as a regulatory anchor in existing industry working groups (like BRAVE) to help develop validation frameworks for generative and agentic AI.

Retinex, Inc., an AI-native electronic medical record system company, supports the pilot program while suggesting specific improvements to its framework. They argue that the Agency should recognize electronic health record systems as a distinct participant category and expand the infrastructure requirements to include upstream data production at clinical sites.

Melinda B. Chu, CEO and Founder of Cythera Bio, supports the FDA's pilot program to integrate AI into early-phase clinical trials. She argues that the program should initially focus on therapeutically simpler platforms, such as topical or intranasal products, to establish transferable methodologies before moving to more complex modalities like cell and gene therapies.