For decades, a cancer patient’s access to cutting-edge therapies has been largely delimited by their proximity to an academic medical center. Recent advancements in clinical trial decentralization have begun to loosen that restriction.
Between 2018 and 2019, HHS implemented a revised Common Rule, enabling healthcare institutions to operate under a single institutional review board rather than conducting separate reviews at each clinical trial site. This change helped reduce duplicative oversight and administrative burden. In 2020, NIH followed suit with a similar policy that permitted NIH-funded multisite studies to operate under a single institutional review board.
In 2024, the FDA finalized guidance on conducting clinical trials with decentralized elements, outlining how operations could occur outside traditional research sites and providing recommendations on how to maintain data integrity, patient safety and regulatory compliance.
With these regulatory shifts, health systems across the U.S. have begun building out clinical trial infrastructures, either within their own organizations or through specialized partnerships.
As clinical trials cease to be a niche academic function and become a core component of oncology care delivery, health systems that opt to participate are faced with the challenge of not only identifying eligible patients but also enrolling and supporting them throughout the trial journey.
Clinical trials as a systemwide model of care
One such system is Charlotte, N.C.-based Advocate Health, which launched a systemwide clinical trial network in November, three years after Charlotte, N.C.-based Atrium Health and Advocate Aurora Health, then dually based in Downers Grove, Ill., and Milwaukee, merged to create one of the largest nonprofit health systems in the country.
The network, Advocate Health National Center for Clinical Trials, aims to make clinical research part of routine care across the health system’s 69 hospitals, more than 1,000 care sites and nearly 6 million patients across six states.
Jamy Ard, MD, chief science officer at Advocate Health, and director of the Clinical and Translational Science Institute at Winston-Salem, N.C.-based Wake Forest University, serves as clinical lead for the network. He spoke to Becker’s about why a systemwide network made the most sense for clinical trial expansion.
“It hasn’t been a choice of whether we do clinical trials or not, because we were already doing clinical trials, but it was done in a given region with a given investigator across the health system,” Dr. Ard said. “What we’ve been able to realize is that we now have the infrastructure, including things like one Institutional Review Board for the entire health system, two instances of Epic across all of our providers and locations, and a unified cloud data platform. All of that infrastructure really enables us to think about clinical trials as a model of care.”
National expansion tests activation and enrollment
Another system expanding clinical trials across state lines is Duarte, Calif.-based City of Hope, an independent, comprehensive cancer center network spanning California, Arizona, Illinois and Georgia.
Edward Kim, MD, vice physician-in-chief at the City of Hope National Medical Center and physician-in-chief at Irvine-based City of Hope Orange County, oversees research initiatives across the cancer center’s growing national footprint. He recently joined the “Becker’s Healthcare Podcast” to sharemore about the journey of establishing a national cancer trial network.
“It took us about a year to fourteen months to get the infrastructure in place. [When we] launched our first set of clinical trials, they opened simultaneously across all our sites, five major campuses in Los Angeles, Irvine, Chicago, Atlanta and Phoenix, as well as any other of our regional sites that exist in the City of Hope network,” Dr. Kim said. “That was all covered by a single IRB, single [principal investigator], single contract. We have […] access to 86,000,000 lives within ninety minutes of all of our sites across the country. We are consenting people into a trial within the first two weeks of activation and enrolling our first patient within thirty days. [Our model] truly has shown that if you can scale an office, provide access to patients closer to where they live, they will engage in clinical trials.”
A partnership approach to early-phase trials
Other health systems have taken a partnership-driven approach to expand clinical trial access.
In 2024, New Hyde Park, N.Y.-based Northwell Health and the START Center for Cancer Research — a global network of clinical trial sites — partnered to bring an early-stage clinical trial site to Northwell’s R.J. Zuckerberg Cancer Center, also in New Hyde Park.
The model combines START’s global trial expertise with Northwell’s large, community-based patient population. Richard Carvajal, MD, medical director and deputy physician-in-chief of medical oncology at the Northwell Cancer Institute, spoke to Becker’s about the decision to partner with START rather than build the capability entirely in-house.
“All cancer programs are going to say [trial capability] is a critical piece that they need to develop, but there are different challenges depending on the setting,” he said. “In smaller community settings, they’ll have the patients and physicians but maybe lack a little bit of the knowledge required to build infrastructure. On the other end of the spectrum, with our traditional academic centers where there’s deep expertise and a long history of doing trials like this, there’s frequently a lack of efficiency for various reasons. Together, Northwell and START saw an opportunity to do things differently. We’ve got the community-based oncologists who want to give their patients access to these therapies and then we have the expertise of START— it’s an incredible marriage and something that hasn’t been done before.”
Redesigning research environments for scale
Many cancer centers have embraced the traditional academic medical center clinical trial setting, harnessing the recent regulatory shifts to strengthen research capabilities.
Miami-based Sylvester Comprehensive Cancer Center — part of the University of Miami Health System and Miller School of Medicine — doubled its research footprint with the opening of its Griffin Cancer Research Building in fall 2025.
The building’s research facilities include AI-driven dry labs and laboratories organized into “neighborhoods” to promote cross-team collaboration alongside 27 infusion bays, imaging suites and an onsite pharmacy.
Cleveland-based University Hospitals Seidman Cancer Center — a founding member of the Case Comprehensive Cancer Center at Case Western Reserve University, also in Cleveland — will triple its clinical trial capacity by 2030. Fueled by a $3.5 million donation, the move is part of a broader push to expand cancer research and innovation while decentralizing early-phase trial access across its 23-hospital system and 17 Seidman Cancer Center sites.
The next challenge: patient identification
As health systems pursue clinical trial integration, equitable access can be hampered by inconsistent patient identification. Fourteen oncology leaders told Becker’s that access gaps might be bridged by embedding trial screening into routine patient care through EHR integration, automation and AI-driven matching.
“The most effective lever that health systems can pull to expand equitable access at scale is to embed clinical trials into routine care, making trial consideration a standard and expected part of the clinical workflow, not a separate activity,” Advocate Health’s Cancer National Service Line leadership dyad of Ruben Mesa, MD, and Nike Onifade, told Becker’s. “This requires moving beyond individual sites or investigators and building system-level infrastructure that supports trials wherever patients receive care.”
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