Comment from Society for Clinical Research Sites

Please see attached file for full comments. The Society for Clinical Research Sites (SCRS) is the premier global advocacy organization representing 12,000+ clinical research sites across 65+ countries — the workforce that enrolls and treats patients in clinical trials every day. SCRS strongly supports the FDA's commitment to restoring U.S. leadership in early-phase research. Our comments are grounded in our annual Global Site Landscape Survey data collected from sites, sponsors, and CROs, and reflect the operational realities that determine whether accelerated timelines succeed or fail at the point of patient care. Our data tells a clear story: when sites are excluded from protocol development, the consequences are measurable. 24% of sites cite protocol complexity as a top reason for declining trials, 33% identify protocol amendments as a leading cause of study delays, and nearly a third report that 6–20%+ of study opportunities are delayed more than 30 days prior to enrollment due to sponsor or CRO decisions. Conversely, when sites are engaged early and protocols reflect site realities, they move fast, 47% complete contract negotiations and 45% complete budget negotiations in under 30 days. Sites are a speed asset, not a speed liability. Our full comments are attached. In summary, SCRS recommends: - Include sites as QRIs or require site representation within every QRI structure - Require site feasibility assessment as a formal QRI deliverable, not a parallel activity - Protect community and independent sites through tiered qualification pathways - Add site-level metrics to the pilot evaluation framework - Formalize early site engagement as an FDA-recognized quality practice