Comment from Association for Multisite Research Corporations
AnonymousSupportTrade association
Summary: The Association for Multisite Research Corporations (AMRC) supports the FDA's proposed Expedited IND Pilot Program to accelerate drug development while maintaining safety standards. They recommend recognizing experienced Phase 1 clinical trial networks as Qualified Research Institutions (QRIs) and suggest measuring program success through operational metrics like site activation and recruitment performance.
The Association for Multisite Research Corporations (AMRC) appreciates the opportunity to provide comments regarding FDA's proposed Expedited Investigational New Drug (IND) Pilot Program. AMRC represents a nationwide network of leading clinical research organizations conducting research across a broad range of therapeutic areas and patient populations. Our members collectively operate 466 research sites across seven countries and engage millions of patients throughout the United States.
AMRC strongly supports the goals of the FDA's Expedited IND Pilot Program and the broader vision of accelerating the development of innovative therapies while maintaining rigorous standards for participant safety, scientific integrity, data quality, and regulatory compliance. We believe this initiative presents a significant opportunity to strengthen U.S. clinical research infrastructure, improve patient access to clinical trials, and reduce unnecessary delays between drug discovery and first-in-human (FIH) clinical evaluation.
Our full comment is attached.