Comment from ALS Network
AnonymousSupportAdvocacy
Summary: The ALS Network, an organization advocating for people with ALS, supports the FDA's pilot program for using AI to optimize early-phase clinical trials. They argue that while AI can significantly improve trial efficiency and patient selection for rapidly progressive diseases, it must be used as a decision-support tool governed by rigorous standards for transparency, validation, and patient safety.
ALS Network respectfully submits the attached comments in response to the Food and Drug Administration's Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Please see the attached document for our full comments and recommendations.