Comment from Digital Trials and Research Alliance
AnonymousSupportAdvocacy
Summary: The Digital Trials & Research Alliance (DTRA), a nonprofit public-private partnership, supports the FDA's AI-enabled clinical trials pilot program. They offer to serve as a neutral facilitation partner to help define use-case-specific KPIs, develop centralized testing datasets, and conduct stakeholder listening sessions to ensure the program's success.
Please find enclosed comments submitted on behalf of the Digital Trials & Research Alliance (DTRA) in response to FDA's Request for Information on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (91 FR 23100, April 29, 2026).
DTRA welcomes the opportunity to discuss these comments further and stands ready to support FDA's work on this initiative.
Respectfully submitted,
Craig H Lipset
Co-Chair, Digital Trials & Research Alliance
www.dtra.org