Comment from BurnaAI Inc
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Summary: Burna AI, Inc., a company developing safety and data quality platforms for oncology drug development, supports the proposed pilot program for AI-enabled optimization of early-phase clinical trials. They recommend specific focus areas such as real-time safety monitoring, human-in-the-loop collaboration models, and the inclusion of workforce burden reduction as a key success metric.
This comment is submitted by Burna AI, Inc., a CancerX member under the
HHS Cancer Moonshot Initiative building the safety and data quality
platform for oncology drug development. Our detailed responses to the
questions raised in RFI Docket FDA-2026-N-4390 are in the attached
document. We welcome continued engagement with the Agency on the safe
deployment of AI in early-phase clinical trials.