Comment from RTI International
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Summary: 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.
RTI International and Savana appreciate the opportunity to provide feedback on the FDA’s Request for Information - "AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program" (Docket No. FDA-2026-N-4390). Please find our formal response attached as a PDF.