Led by U.S. Congressman Jake Auchincloss (D-MA), the Cures in Care Initiative seeks to modernize the U.S. clinical trial framework by integrating research into routine healthcare. Its goal is to expand patient access while safely accelerating drug development and approval.
AMRC responded on behalf of our members in support of the initiative’s overall direction, while urging Congress to introduce stronger requirements for research infrastructure, workforce training, quality oversight, governance, and partnerships with experienced research organizations. These safeguards are essential to ensure that expanding access does not compromise patient safety, data integrity, or GCP compliance.
AMRC’s Full Submission
Founded in 2024, the Association for Multisite Research Corporations (AMRC) was established by its founding members to advance the benefits of working with multisite clinical research corporations (MCRCs) to streamline, accelerate, and improve the quality of clinical research. Currently, we represent 19 organizations and more than 560 sites globally.
AMRC supports the overall goal of the Cures in Care Initiative, which seeks to expand clinical trial access by integrating research into routine healthcare settings and community practices. We agree this approach could improve patient access, accelerate clinical development, and reduce trial costs. The question is not whether to expand participation, but how to do so while delivering the reliability, quality, and data integrity that drug development demands.
Clinical care and clinical research require different expertise and infrastructure. There is a risk in conducting FDA-regulated research with the assumption that healthcare organizations can begin research without the infrastructure and expertise that experienced research organizations provide. Regulatory oversight, quality systems, investigator training, patient safety, recruitment, and study execution are all critical components of successful clinical research. MCRCs and research organizations should be viewed as enablers of this model, not bypassed by it.
Without dedicated coordinators, regulatory personnel, and oversight processes, there is increased risk of protocol deviations, poor documentation, delayed safety reporting, and inconsistent data.
This last point deserves emphasis. The initiative’s data and interoperability provisions are not sufficient on their own. High-quality, regulatory-grade data depends on trained personnel and standardized processes. Variability in data quality across participating organizations could undermine the reliability of study outcomes and regulatory submissions. MCRCs have invested in standardized, network-level data systems and quality processes that produce consistent, inspection-ready data at scale, precisely the capability the initiative’s interoperability goals rely on.
Access to patients does not automatically translate into successful recruitment. Effective enrollment requires specialized outreach, education, screening, scheduling, retention, and follow-up. Adding sites is not the same as adding reliable capacity; delivering predictable enrollment across sites for a single study is an operational discipline, not a byproduct of patient volume.
AMRC recommends that Congress require participating organizations to meet minimum research infrastructure standards, including research leadership, trained coordinators, quality management systems, regulatory support, research-specific SOPs, and performance metrics. AMRC also supports a tiered accreditation model allowing newer sites to begin with lower-risk studies before assuming more complex responsibilities, and models in which community organizations partner with experienced research networks for training, oversight, quality management, recruitment, and study operations. This expands access while preserving rigor, and recognizes MCRCs, which have built specialized infrastructure over decades, as essential stakeholders in the initiative.
We also urge that the legislation explicitly address diverse participant representation, which it currently omits, and strengthen US-based trial capacity.
AMRC’s position is that the legislation is directionally correct but should require stronger training, infrastructure, governance, and partnerships so expanded access does not compromise quality, safety, or data integrity. Increased access, faster enrollment, and lower costs are worthy goals, but cannot come at the expense of data integrity, patient safety, or GCP compliance.
