Re: Docket OSTP-TECH-2025-0100
The Association of Multisite Research Corporations (AMRC) appreciates the opportunity to comment on this important Federal policy update on accelerating the American scientific enterprise. AMRC applauds any initiative to advance science and clinical trials to the benefit of patients.
About the Association of Multisite Research Corporations (AMRC)
Founded in 2025, AMRC represents more than 530 sites, over 1,600 principal investigators and nearly 9,000 employees dedicated to advancing the quality, efficiency, and scalability of clinical trials. Our members constitute an invaluable strategic national infrastructure. In addition to representing some of the largest site networks in the world, AMRC members include small and mid-size operations with strong regional networks.
Multisite clinical research corporations (MCRCs) play an increasingly central role in clinical development. They bring scale, speed, and consistent operations. Our research suggests that, across 23 operational areas, Sponsors and Contract Research Organizations (CROs) selected MCRCs as best-in-class 26% of the time, almost equal to Academic Medical Centers (AMCs) at 29%. MCRCs are highly associated with consistency, faster start-up, scalable infrastructure, and access to diverse patient populations.
Recognizing MCRCs as Strategic National Infrastructure
The clinical research delivery infrastructure, particularly large, integrated site networks, is an under-recognized but critical component of the U.S. scientific enterprise. Federal policy still treats clinical research sites as interchangeable, transactional vendors, rather than as long-term partners in translational science. Unfortunately, this model demonstrably slows enrolment, increases cost variability, and undermines reproducibility.
AMRC recommends:
- Federal agencies should explicitly recognize and engage MCRCs as strategic delivery partners.
- Federal policy should enable longer-term master agreements and pipeline-based partnerships between Sponsors, CROs, and site networks.
- Stable partnerships improve start-up speed and recruitment predictability, reducing the time from discovery to real-world impact.
Overcoming Operational Bottlenecks in Biomedical Translation
Currently, the biggest bottleneck in biomedical translation is not discovery but the execution of clinical trials. Federal investments in research routinely stall due to fragmented site activation and inconsistent data quality. These are operational failures, rather than scientific ones.
AMRC suggests OSTP should promote execution-aware translational policy, including:
- Performance Incentives: Models that reward “first-patient-in” timelines and enrollment speed rather than just publications.
- Empirical Data Integration: Incorporating site-level performance data (startup time, deviation rates, etc.) into grant and program design.
- Portfolio-Based Funding: Piloting models where delivery partners are selected once and reused across multiple studies to increase ROI on federal R&D spend.
Developing Talent and Fostering Scientific Collaboration
AMRC enthusiastically supports promoting ways to better identify and develop scientific talent and foster collaboration among healthcare professionals. Our members are identifying, training, and developing clinical research site staff on a regular and consistent basis. AMRC’s wide-ranging national and local networks can help advance these and other national healthcare goals.
AMRC thanks you for the opportunity to comment on this important initiative.
Sincerely,
Jim Kremidas Executive Director, AMRC
