Initiative

The Site Voice in Clinical Trial Reform

The major clinical trial policy reforms shaping the next era of U.S. drug development are being written without sites in the room. These are the same organizations that enroll patients, execute protocols, and absorb the operational consequences when a policy is designed without their input. SCRS closes that gap, putting 12,000+ sites’ operational experience and data directly in front of FDA, Congress, and the institutions shaping the next generation of U.S. clinical development, so reform is built on how trials actually run, not just how they’re intended to run on paper. 

Closing the Gap Between Policy and Practice

Federal clinical trial policy is being redesigned around sponsors, CROs, academic medical centers, and health systems, not the sites that actually enroll and treat patients. That absence isn’t a technicality; it’s why these same policies keep producing the problems they’re meant to solve. Protocols built without site input lead to amendments and enrollment shortfalls. SCRS closes this gap by bringing site-level data into policy development before it‘s finalized, so reform is executable in practice, not just sound on paper. 

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Organizations supporting SCRS' Public Policy Initiative

Program Goals

1

Advance site-informed public policy with FDA, Congress, and regulators, backed by site-driven data. 

2

Monitor and respond quickly to emerging policy issues before decisions are finalized. 

3

Educate policymakers and mobilize members around the value of clinical research sites. 

Supporting Organizations

Key Milestones

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May 2026

Duke-Margolis Institute — Modernizing U.S. Clinical Trials Infrastructure

Flagged the absence of dedicated research sites from the “health care organization” delivery model; called for site inclusion in workforce, data-burden, and pre-certification frameworks

June 2026

Auchincloss Next-Generation Cures in Care Initiative

Identified four structural gaps of operational model blind spots, ambiguous site inclusion, unfunded burden-shifting, and missing co-design and provided five formal recommendations. 

July 2026

FDA Operation TrailBlazer — Expedited IND Pilot Program

Recommended sites be named Qualified Research Institutions (QRIs) or required QRI partners, with site feasibility as a formal deliverable. 

August 2026

FDA Master Protocols for Drug and Biological Product Development (draft guidance)

Recommended a site-facing notice standard for substudy/arm changes, operational guidance for rolling re-consent, and equity review of site-level drug allocation. 

Site Success Impacts Everyone In Research

Be a part of the impact.