In Brief: Decentralized clinical trials (DCTs) are reshaping oncology research by expanding patient access, reducing travel burdens, and engaging diverse populations. This series presents case studies of early-phase and hybrid trial models, detailing institutional challenges such as staffing limitations, regulatory oversight, and cultural resistance. Articles describe pilot design and network implementation strategies; operational considerations such as workflow standardization, training, safety monitoring, and early outcomes; and lessons learned for scaling DCTs across clinical programs.
Spanning 320,000 square miles of the upper Midwest, Sanford Health serves more than 2 million patients across eight states. This is a landscape of pure juxtaposition, with vast open prairies and frontier communities, punctuated by regional cities that serve as hubs for commerce, innovation, and advanced medical care. Sanford Health covers this entire footprint with 58 medical centers and 289 clinic locations. As the largest rural health system in the United States, Sanford has built its identity around a core conviction: Where a patient lives should never determine the care they can access. That conviction is precisely what has driven the health system’s deliberate, patient-centered expansion into decentralized clinical trials (DCTs).
With more than 500 scientific staff, 1,100-plus active clinical trials and studies, and a physician workforce spanning more than 80 specialty areas, Sanford has significant research infrastructure. But for the rural patients who make up a large portion of its population, access to that infrastructure has not always been straightforward. The DCT program addresses that gap directly.
Sanford’s decentralized trial journey did not begin with a large strategic plan. It began with a single physician’s determination to reach her patients. In 2015, Maria Bell, MD, MPH, MBA, who is the Chief Medical Officer at Sanford Research, was Sanford’s only gynecologic oncologist at the time, and was traveling between Sioux Falls, South Dakota, and Fargo and Bismarck, North Dakota, as well as to other regional sites to deliver care. She had always viewed clinical trials as a standard of care, and she was not willing to let geography become a barrier for her patients.
“Her passion and her wish to be able to give the same quality of care…that’s really what started it,” said Eleanor (Ellie) Gibbons, CCRP, Clinical Research Operations Manager for Sanford’s south region. Using telemedicine to extend her reach, Dr. Bell began providing clinical trial care to patients at outlying sites who would otherwise have had no access. Nearly a decade later, approximately 95% of her trials continue to incorporate decentralized elements.
A workaround for one provider’s geographic challenge evolved into something larger when Sanford launched its Virtual Care Center, a system–wide initiative designed to bring modern medicine to communities where physicians cannot go. The Virtual Care Center provided both seed funding and institutional momentum, enabling Sanford to hire a dedicated DCT Navigator, a role that would become the backbone of a formalized program.
Before the program could expand, the team needed a clear picture of what was possible. Working with the Virtual Care Center, they undertook the painstaking process of cataloging capabilities across every clinic and facility in its vast footprint. Staff made call after call to sites across the coverage area, mapping out which locations had laboratory processing capabilities, infusion centers, pharmacy staff, chemotherapy administration capabilities, telemedicine infrastructure, and more.
The result was a comprehensive capability grid. Today, this living resource continues to help the DCT team visualize exactly what each site can support. “When you look at all those clinics, we now have the grid filled out for each of them,” explained Kassandra Remmel, Clinical Research Operations Manager for Sanford’s north region. “We know infusion, radiology, lab, the whole thing.” That grid has become an essential planning tool: When a patient is identified in a remote location, the team can quickly determine which trial activities can be brought closer to home.
Financially, building the grid required more staff time than new capital. The mapping process was absorbed into existing operations managers’ workloads rather than a formal budget request, which lowered the bar for getting started. The larger investment is the DCT Navigator role itself, currently funded through the Virtual Care Center initiative rather than the research budget. The expectation, according to Lora Black, RN, MPH, CCRP, Vice President of Clinical Research, is that the position becomes self-sustaining over time through grant funding or commercial trial reimbursement, at which point it will move to a dedicated line item in Sanford’s research budget.
In September 2025, Sanford hired Sophia Connelly as its first DCT Navigator, a role that sits within the research team but is funded through the Virtual Care Center initiative. Connelly describes the first months as equal parts learning curve and foundation-building. As a former oncology clinical research coordinator, she understood the trial landscape but quickly learned that decentralized care requires collaboration across the health system.
“It’s going to touch every department within clinical research in some capacity,” Connelly said. Her days include shadowing regulatory and finance teams, engaging with sponsors and cooperative groups, such as the Alliance for Clinical Trials in Oncology and the NCI Community Oncology Research Program (NCORP), and fielding requests from coordinators and providers across the system. She has also connected with peer organizations, including Mayo Clinic’s Clinical Trials Beyond Walls program and the Decentralized Trials & Research Alliance (DTRA), to learn from others navigating similar terrain.
The DCT Navigator role was modeled in part on the success of a similar position created for Sanford’s early-phase clinical research program, where they saw demonstrably accelerated growth with the utilization of an early-phase nurse navigator.
To secure support for the new DCT Navigator role, leadership presented a clear case to the C-suite: Patients in rural communities deserve the same access to clinical trials as those treated at major academic centers, and the navigator role would provide the infrastructure needed to bridge that gap.
For Black, the message was simple. “This is absolutely what we should be doing, and it’s mission-critical to everything that we stand for,” she said.
The proposal quickly gained traction. “I only had to make one C-suite presentation,” she recalled, “and that was in conjunction with the leader from the Virtual Care Center. Then this team just hit the ground running.”
One of the most distinctive aspects of Sanford’s DCT approach is its de facto motto: Accept the request, figure out the path. The team has been deliberate about not reflexively declining when a sponsor, protocol, or logistical constraint initially seemed to make decentralization impossible.
In practice, this has meant starting with the lower-hanging fruit, such as having pretreatment labs drawn locally the day before a visit so patients do not have to make a long drive only to be potentially turned away for out-of-range values, or having scans completed at a nearby Sanford facility. It could also include growth factor injections administered close to home.
But the team has also taken on more complex scenarios. In one notable case, a local patient was enrolled on a phase 1 oral agent study at an academic center on the West Coast. When an adverse effect temporarily prevented the patient from traveling, Sanford’s DCT team worked with the academic center to arrange a local physical exam and PET scan. When the sponsor initially pushed back on shipping the investigational agent, the team continued to engage until approval was secured, providing education on what was permissible under current DCT guidance.
“Even if it’s a ‘no’ right now, we don’t want our physicians to think it will always be a ‘no’,” Gibbons explained. “We’re taking these as learning opportunities to see how we can overcome barriers when we come up against them.”
Connelly has noticed a parallel shift externally. “I’ve been pleasantly surprised by how open to discussion, and to flexibility, some commercial sponsors are to implementing DCTs,” she said. “The more often we spark these conversations, the faster adoption is going to become more widespread.”
Sanford’s DCT program operates through a layered governance structure. A small working group meets weekly to process active requests, a larger operational team convenes monthly, and a steering committee meets quarterly. The steering committee is composed of approximately 16 to 18 members from operations, regulatory leadership, finance, legal, institutional review board, and compliance, in addition to physicians and a project management representative. Ad hoc meetings are called when a request requires immediate cross-functional input.
The program is in what the team describes as phase 1: It is building the foundational standard operational procedures and policies that will allow DCT elements to be embedded into trials from the outset rather than retrofitted when a patient need arises. Phase 2 will focus on integrating DCT considerations directly into study startup and trial selection conversations. Phase 3 will formally expand into nononcology populations.
The DCT team is also working hard to define what success looks like. Metrics under development include patient satisfaction questionnaires, tracking miles saved per patient, and longitudinal monitoring of enrollment and retention rates.
For cancer programs considering their own DCT initiatives, the Sanford team offers some hard-won observations, as follows:
Sanford Health’s aspiration to be the premier rural health care system in the US is not just a marketing tagline. It is an organizing principle that shapes decisions at every level, from C-suite investment in infrastructure to a DCT navigator fielding a request on a Tuesday afternoon. The DCT program is, in many ways, that mission made operational.
That mission-first case, rather than a financial model, is what got the program off the ground, but the return is starting to show up on both sides of the ledger. For patients, it is measured in miles not driven and appointments not missed, data the team has begun tracking alongside satisfaction surveys. For Sanford, the payoff looks different: Coordinators and providers who once absorbed DCT logistics on top of a full trial workload now have a single point of contact managing that complexity, and the health system is positioning itself, through partnerships with NCORP and DTRA, as a model other rural systems can learn from. It is a win for which Sanford is still building the data to prove, but one leadership was confident enough in to act on before the numbers existed.
The team is already looking beyond its borders. Black sees Sanford’s rural positioning as an opportunity not just to serve its own patient population, but to help establish models that others can follow. “We’re in a position where we can help,” she said. “I’d really like to find ways to collaborate and make standards for people to follow.” Working with partners such as NCORP and DTRA, Sanford is contributing to the broader field and sharing what it is learning so that rural patients everywhere have a better chance at access to clinical innovation. Now that is 320,000 square miles of reason to keep building, and it is just the start.
Explore additional resources at accc-cancer.org/ACORI.
Nadine J. Barrett, PhD, MA, MS, FACCC¹,²; Shaalan Beg, MD, MBA, FASCO³; Al B. Benson III, MD, FACP, FASCO⁴; Lora Black, MPH, RN, CCRP⁵; Christa Braun-Inglis, DNP, APRN-Rx, FNP-BC, AOCNP⁶; Carrie Friedman, BSN, RN, OCN⁷; Una Hopkins, DNP, MSN, RN, FNP-BC, NE-BC, FACCC⁸; Michele Lacy, BSN, RN, OCN⁹; Marc Matrana, MD, MSc, FACP¹⁰; Jane Myles, MSc¹¹; Amy Peterson, PhD, GPC¹²; Wyatt Pickner, MPH¹³; Lawrence Wagman, MD¹⁴, Elana Plotkin¹⁵; Rifeta Kajdić Hodžić, CHPM¹⁵; Carolyn Trachtenbroit¹⁵; Molly McHale, MSN, FNP-BC¹⁵; Meagan O’Neill¹⁵
¹Wake Forest University School of Medicine; ²Advocate Health; ³ConcertAI; ⁴Robert H. Lurie Comprehensive Cancer Center of Northwestern University Hospital; ⁵Sanford Health; ⁶University of Hawaii Cancer Center; ⁷Virginia Cancer Specialists; ⁸Montefiore Health System; ⁹Metro Minnesota Community Oncology Research Consortium; ¹⁰Ochsner Cancer Institute; ¹¹Decentralized Trials & Research Alliance; ¹²Munson Healthcare; ¹³American Indian Cancer Foundation; ¹⁴City of Hope; ¹⁵Association of Cancer Care Centers
In partnership with: Decentralized Trials & Research Alliance (DTRA)
Made possible with support from: Gilead, Kite, Lilly, Merck
The Association of Cancer Care Centers (ACCC) provides education and advocacy for the cancer care community. For more information, visit accc-cancer.org.
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