UNC Lineberger expands cancer clinical trials access across NC

Many residents of North Carolina, where 33% of the population lives in rural communities, have little to no access to cancer treatment trials. But UNC Lineberger Comprehensive Cancer Center is changing that through an innovative clinical trial model, with two trials enrolling patients and 20 more in development.

The model is the brainchild of UNC Lineberger’s J. Kaitlin Morrison, executive director of clinical research, and Dr. Carrie Lee, chief medical officer.

Called a hybrid decentralized trial, the model brings clinical trials closer to where patients live, rather than requiring them to drive to Chapel Hill for treatment.

“We at the cancer center have a mission to serve the whole state, and we need to find a way to do that,” Morrison said.

Serving the state of North Carolina

Morrison and Lee are acutely aware of the inconvenience of coming to the N.C. Basnight Cancer Hospital in Chapel Hill for treatment. For example, patients from UNC Health Pardee in Hendersonville, in the far western reaches of North Carolina, face a nearly four-hour drive to Chapel Hill — and then the same drive home.

“I’ve lived throughout the entirety of the state. I’ve lived in the mountains. I’ve lived at the beach. I’ve lived in eastern North Carolina. I know how far it is to travel to Chapel Hill,” Morrison said.

Through the hybrid decentralized clinical trial model, most care and follow-up could take place at a hospital or clinic near the patient’s home. Visits to Chapel Hill would be limited to complex procedures, specialized tests or for expertise in the experimental treatment.

“This approach could improve patient comfort and convenience and reduce geographic and socioeconomic barriers to clinical trial participation, and it would focus on minimizing the administrative burden on the participating hospitals,” Lee said. “It also could help improve recruitment and retention of less studied groups, including rural residents, older adults and those with limited access to care, as well as expedite the overall accrual process.”

Supported by $250,000 in federal funding, including from the Food and Drug Administration’s Office of Minority Health and Health Equity, they launched the Hybrid Operations to Promote Equity – Bringing Trials Closer to Patients study in 2024 to investigate whether UNC Health can successfully conduct hybrid cancer clinical trials across the state.

Engaging with statewide community partners

UNC Lineberger’s clinical trials office and the office of community outreach and engagement staff collaborated closely to create the HOPE Tour, a nearly 1,300 mile fact-finding mission that took them to communities located across the state. They visited nine North Carolina hospitals – from UNC Health Blue Ridge in Morganton to UNC Health Rockingham in Eden to Novant Health New Hanover Regional Medical Center in Wilmington. They met with 120 local administrators and providers during an eight-month period, which ended in March.

The tour provided opportunities for two-way learning. It also underscored the role each partner has in caring for patients, the value of collaboration and the importance of local providers sharing clinical trial opportunities with their patients.

Equally important, community partners expressed enthusiasm for helping to run clinical trials, seeing their involvement as a sign of high-quality cancer care.

The initiative, even in its early stage, is generating national attention.

Morrison was awarded second place for her research abstract on UNC Lineberger’s hybrid clinical trials initiative at the Association of American Cancer Institutes’ clinical research innovation meeting in Chicago in June.

“It is always gratifying when others tell you that your research matters, but I am more excited that our program is being well received by our community partners and that together, we are making clinical trials accessible to more people throughout North Carolina,” Morrison said.

Read more about the clinical trials initiative.