Comment from Highlander Health
AnonymousSupportAdvocacy
Summary: Highlander Health, an organization focused on evidence generation innovation, enthusiastically supports the FDA's proposed AI-enabled clinical trials pilot program. They argue that the pilot should prioritize specific use cases like oncology dose optimization and safety signal detection, utilize a tiered risk-management framework, and foster pre-competitive collaboration through a neutral convener and shared knowledge repositories.
To the Food and Drug Administration:
Thank you for publishing the Federal Register notice entitled “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information” (FDA-2026-N-4390). Highlander Health appreciates the Agency’s commitment to assessing how artificial intelligence (“AI”)-enabled technologies can improve efficiency, speed, and quality of decision-making in early-phase clinical trials, and we applaud the Agency for translating its growing experience with AI submissions into a concrete pilot program.
Highlander Health enthusiastically supports the Agency’s work in this area and looks forward to collaborating with FDA, CDER, CBER, and the broader stakeholder community in developing the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Please see our attached comments on this topic and contact Nicholaas Honig at Nickh@highlanderhealth.com with any questions regarding these comments or other issues related to evidence generation policy and infrastructure.