Local HCPs In DCTs: A Game-Changer For Oncology Trials
By Dan Schell, Chief Editor, Clinical Leader
When the FDA clarified that local healthcare professionals (HCPs) involved in DCTs do not need to be listed on Form FDA 1572 (as long as they only perform standard-of-care procedures and are not engaged in research), it initially raised concerns within the clinical research community. The American Society of Clinical Oncology (ASCO) was among the organizations that voiced early apprehension. ASCO feared that omitting local HCPs from the 1572 could lead to insufficient oversight, posing potential risks to patient safety and data integrity. They worried that accountability gaps might arise if something went wrong during trial execution.
However, over time, ASCO’s stance evolved. After dialogue with the FDA and further clarification, ASCO acknowledged that with appropriate oversight by the trial’s PI and the sponsor, patient safety could be maintained without unduly burdening local providers. They recognized that this approach could enhance patient access to trials without compromising scientific rigor or regulatory compliance — a shift that aligned with broader efforts to expand clinical trial participation, particularly among underserved populations. To further address oversight concerns, trial sponsors and investigators often maintain a detailed task log documenting the involvement of local HCPs, which ensures accountability for patient care activities.
Against this backdrop, Kaitlin Morrison, Ph.D., Executive Director of LCCC Clinical Research at UNC Lineberger Comprehensive Cancer Center, is leading an innovative initiative that leverages local HCPs in DCTs to address access barriers and enhance community-based clinical research.
Laying the Groundwork with Cell Therapy
Morrison’s experience with decentralized models began nearly a decade ago through necessity while working on CAR-T cell therapy studies at UNC. These gene therapy trials required long-term follow-up, often up to 15 years, but the center was attracting patients from as far away as Australia. “If the patient is doing well, they won’t want to travel that far regularly,” Morrison explains. “And if they’re doing poorly, they often can’t.” The solution: Allow follow-up visits to be conducted by local healthcare providers who collected clinical data and blood samples for UNC. This workaround not only enabled compliance but helped plant the seed for a more sustainable DCT model that prioritized patient-centered care and accessibility.
Addressing North Carolina’s Access Gaps
North Carolina’s diverse geography, stretching from the Appalachian Mountains to the Atlantic coast, presents significant challenges for patients trying to access centralized academic medical centers. Many patients, especially those in rural or medically underserved areas, face travel times of up to four hours to participate in clinical trials. For oncology patients dealing with fatigue, financial strain, and frequent appointments, this burden often deters participation altogether.
Rather than replicating traditional research infrastructure across the state, Morrison and her team designed a more pragmatic solution: work with local oncologists who already care for patients. Under this model, these HCPs deliver standard-of-care procedures within the patient’s local community while research elements are centralized and coordinated by UNC Lineberger.
This keeps the model nimble and avoids unnecessary regulatory complexity. Still, Morrison emphasizes the importance of clear expectations. UNC Lineberger holds concise “launch meetings” with each local provider, explaining the protocol, establishing communication channels, and ensuring the provider feels supported. While providers aren’t trained as researchers, these meetings help create alignment without administrative overload.
A Win-Win for Local Providers
Convincing local providers to participate in this hybrid model has not been difficult, Morrison reports. Many community cancer centers are accredited by the Commission on Cancer or other entities that require referring eligible patients to clinical trials. By enabling access without pulling patients away from their local provider for routine care, the model supports those accreditation goals.
It also offers financial and logistical incentives. Providers continue billing for standard care, while non-standard research procedures such as additional imaging or lab draws are reimbursed through simple vendor agreements. This setup avoids the complications of subcontracting research responsibilities.
“Access to clinical trials is seen as access to quality care,” Morrison explains. “Providers view participation not just as a service to patients but also as a way to elevate their practice.”
(Editor’s note: For more on this approach, see my articles Local HCPs In DCTs: Big Benefits, Bigger Burdens and 7 Steps To Manage Local HCPs In A Decentralized Trial.)
Working Closely with the FDA
The development of the UNC model was also shaped by consistent collaboration with the FDA. When Morrison and her team piloted the initiative to expand access to community-based patients, they submitted a grant to the FDA’s Office of Minority Health and Health Equity and were selected, in part, because of their emphasis on continuing decentralized innovation post-pandemic. The relationship with the FDA became a key asset. “We met monthly with them to talk about what we’d done, what our plans were, and what that looked like,” she says. These conversations helped Morrison refine strategies to engage local providers and reach underserved patients. The FDA’s support also validated the approach at a time when momentum around DCTs had slowed after rapid growth during COVID. Their feedback ensured the model developed with rigor, practicality, and equity in mind.
Improving Trial Enrollment Statewide
One major motivation behind the local HCP model was improving trial accrual. UNC Lineberger, as an NCI-designated comprehensive cancer center, is accountable for demonstrating that its trial enrollment reflects the demographics of the state. During the COVID-19 pandemic, like many academic centers, UNC saw its accruals drop — a troubling trend given its obligation to represent all North Carolinians.
In 2024, Morrison and her team launched a pilot program at a single community site to test the local HCP model. Across two investigator-initiated trials, that site enrolled 22 patients — an impressive outcome for oncology research.
Encouraged by the pilot’s success, the team embarked on a statewide “tour” to recruit more providers. Nine additional community sites have since joined the initiative. These sites span different geographies and populations, helping Lineberger better serve the entire state. Looking ahead, Morrison hopes to open over 20 new trials using the same decentralized model. The early results suggest the strategy could become a blueprint for expanding access without sacrificing quality.
Maintaining Regulatory Rigor
Morrison’s background in regulatory affairs has been instrumental in structuring the model for compliance and quality. “We knew there couldn’t be any regulatory shortcuts just because we were doing things differently,” she says. Therefore, Morrison and her staff developed tailored data management and monitoring plans that account for the decentralized elements. They apply risk-based monitoring principles, focusing oversight on areas of greatest concern while reducing unnecessary site burden.
Importantly, local HCPs do not manage research records or source documentation. Clinical data is pulled directly from the patient’s EHR, reducing risk of error and easing provider workload. Central monitors flag any data inconsistencies and coordinate with the central research team to resolve them.
This centralized model helped reassure both internal stakeholders and the FDA. Morrison notes that regulators remained comfortable with the setup, even as the pandemic accelerated adoption. By demonstrating robust oversight, Lineberger was able to maintain trust while innovating.
Although the UNC model is currently limited to investigator-initiated studies, Morrison sees strong potential for expanding into industry-sponsored research. Sponsors have been slower to embrace the approach due to questions around compliance, logistics, and data flow, but Morrison believes UNC’s success can serve as proof of concept. “Yes, the barriers are real, but the potential is even greater. We’ve shown that with flexibility, regulatory rigor, and a patient-centered focus, decentralized models can truly transform oncology research.”
For more information on DCTs in general, check out A Guide For Managing Decentralized Clinical Trials.