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Vince Lombardi once said, “The only place success comes before work is in the dictionary.” I cannot think of a more fitting quote when it comes to the topic of decentralized clinical trials. At University of Chicago Medicine (UChicago Medicine), we have been committed to this work for more than 14 years, and our progress has required tremendous effort. A large academic medical center, UChicago Medicine is located in Chicago’s Hyde Park (see the star in Figure 1).
In 2011, UChicago Medicine acquired a private oncology practice in the suburbs, about 35 miles from our main campus in Chicago. That acquisition marked the beginning of our decentralization journey. The process demanded extensive collaboration with a wide range of stakeholders, including principal investigators, treating physicians, and teams from regulatory, legal, pharmacy, finance, nursing, and many others. The success of that first suburban site—and its clinical trial growth—sparked a chain reaction that inspired us to bring research opportunities closer to patients across our region.
Since that first acquisition, UChicago Medicine has continued to build, acquire, merge, and partner with locations across our communities and service our catchment area (Figure 2). Each location offers unique advantages to UChicago Medicine in terms of clinical trial accrual. For example, starting up clinical trial enrollment at Ingalls Hospital, a local safety net hospital, has increased our recruitment of individuals from minority backgrounds and significantly strengthened our commitment to those communities. Today, our integrated network contributes 20% of the participants enrolled in cancer treatment studies at UChicago Medicine. We have also built a system that allows patients to move seamlessly through our network. In fiscal year 2025, over 3000 procedures were conducted at a network location for clinical trial participants enrolled at our main campus (Figure 3).
Setting the Stage
The importance of clinical trials is indisputable; they remain the only pathway to introducing new therapies and improving existing ones. Yet access remains a significant challenge. In 2024, the team at Fred Hutchinson Cancer Center in Seattle, WA, did a thorough review of clinical trial enrollment for cancer centers that participate in the Commission on Cancer (CoC) accreditation program. Across all sites, they found that clinical trial participation in treatment studies was 7.1%.1 The team was able to further break that down by type of institution, finding that academic medical centers have an accrual rate closer to 22%, while community cancer programs have an accrual rate of 4.1%.1
Many factors contribute to these low participation rates, but at the core is the reality that the health care system places an undue burden on patients to participate in clinical trials. Commonly cited barriers include geographic distance to trial sites, financial constraints, time away from work and family, burdensome research procedures, and limited availability of translated study materials.
The Promise of Decentralization
Decentralized clinical trials came into wider acceptance during the COVID-19 pandemic, bringing care to the patient instead of the patient having to travel for care. In 2024, the US Food and Drug Administration (FDA) published guidance on decentralized clinical trials: “A decentralized clinical trial refers to a clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites.”2 At UChicago Medicine, we use the term to account for any clinical trial service offered at a location other than our main site in Hyde Park, Illinois. This can take the form of providing clinical trial participants standard-of-care services closer to home at an integrated UChicago Medicine network site or even at a nonaffiliated site (concordant with the FDA guidance), or offering full trial access—consent, enrollment, and treatment—at one of our integrated network sites.
Decentralized clinical trials benefit both community programs (looking to participate as a local research site) and academic medical centers (looking to partner with community programs) by helping to:
Our Decentralization Model
At UChicago Medicine, the University of Chicago Comprehensive Cancer Center manages oncology clinical trial management. We have found that a one-size-fits-all model does not work for our expanding network. Instead, we have chosen to remain flexible, aligning new sites with pathways that best meet both local needs and priorities at the University of Chicago Comprehensive Cancer Center. Table 1 provides an overview of the key differences across these pathways.
There is no one “right” way to move this work forward. Early in the process, we had to revisit policies and workflows that were designed around a one-site system. We had to invest time (and money) to ensure the local site had the right staff and equipment to do the work safely and efficiently. Our decentralized model (Figure 4) relies heavily on using the teams at our main campus to provide the majority of the behind-the-scenes work—budgeting, contracting, regulatory oversight, monitoring, auditing, pharmacy management, etc. On the other hand, services that “touch” the patient can be delivered at the local site. This type of partnership allows UChicago Medicine to minimize the staff needed at the local site and allows the local site to leverage the expertise of UChicago Medicine’s central teams.
Most academic medical centers take a siloed approach to research; different staff members are responsible for patient-facing activities: patient consenting (nursing), coordination (research coordinators), biospecimen collection (phlebotomy), and research sample processing (research labs). At our local sites, we rely on a senior clinical research coordinator to do all those activities. This model required unique training that cut across multiple departments at our main site; it also required the creation of new job descriptions and pay scales. This training is offered virtually to allow research coordinators to participate from their local site. Current research trainings include patient consent, eligibility, disease response, scheduling, serious adverse event (SAE) documentation, and more.
As patient enrollments increase at network sites, we add additional staff. Historically, we used a flat rate of 30 treatment enrollments as the threshold required to add team members, but more recently, we have moved to an acuity-based system, which accounts for the complexity of our early phase studies. Under our model, a research nurse is the second staff member added. These nurses support clinical needs that increase as patient enrollment increases; these providers triage patients, manage adverse effects and dose modifications, and route medications, among other responsibilities. Some of our network sites have accrued enough patients to clinical trials to justify a third staff member. In these cases, we have added an entry-level clinical research coordinator. These coordinators focus on scheduling, administrative, and biospecimen-related needs.
Physician engagement is another critical aspect of decentralization. Most community programs are not designed to allow for the administrative burden required of physicians to open, maintain, and enroll patients in clinical trials. This is where decentralization brings great benefit to community sites: a central principal investigator (PI) with experience in study start-up and oversight takes on all that responsibility. Under our model, PIs are based at our main campus in Hyde Park. This allows community physicians at our network sites to focus on what they do best: treating patients. Under this model, UChicago Medicine has implemented workflows to streamline disease response and image upload, adverse event monitoring and attribution, and central eligibility checks.
Transporting investigational products required numerous meetings with our investigational drug services department, but eventually, we created a system that allows drugs to be couriered (via MedSpeed) while closely adhering to pharmacy regulations and sponsor requirements. Each time a courier is used, a chain of custody form is filled out, and temperature monitoring is conducted. Alternatives to a courier-based system include:
Biospecimen collection, storage, and shipment were other critical aspects of the decentralization process. All senior clinical research coordinators are trained in all facets of biospecimen collection. The University of Chicago Comprehensive Cancer Center leverages an internally designed training, but there are national programs (often free of charge) that offer a similar service.
We also had to ensure that each network site had access to a deep freezer. Deep freezers allow for longer-term storage of biobank specimens, more flexibility to ship samples when convenient for staff versus always having to ship same day, and use of dry ice (some sites get a delivery every other week, some weekly, and some twice a week, based on need). Table 2 outlines several of the other ideas implemented under our decentralized clinical trial model.
Next Steps for Community Sites Looking to Offer Decentralized Clinical Trials
Kristen Kipping-Johnson, MPH, is director of Network Research Operations with University of Chicago Medicine in Chicago, Illinois.
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