More people are surviving cancer today, thanks in part to advances in cancer detection, diagnosis and treatment. Yet not all cancers respond to standard therapies, and others stop responding or become resistant to treatment, prompting some patients to seek out clinical trials testing new treatments.
There are nearly 15,000 cancer treatment trials currently open for enrollment in the U.S. However, not everyone has easy access to these trials. This is especially true in states with large rural populations, like North Carolina, where more than 3.4 million residents—33% of the population—live in rural communities. Although it is becoming increasingly urban, North Carolina has the second-largest rural population in the country.
This access gap has concerned J. Kaitlin Morrison, PhD, and her colleague Carrie Lee, MD, MPH.
Serving the state of North Carolina
“We at the cancer center have a mission to serve the whole state, and we need to find a way to do that,” said Morrison, executive director of clinical research at UNC Lineberger Comprehensive Cancer Center and an assistant professor of medicine at UNC School of Medicine.
Morrison and Lee, chief medical officer for clinical research at UNC Lineberger, have long wanted to bring clinical trials closer to where patients live, rather than require them to drive to Chapel Hill for treatment. Reducing the burden of travel, including logistical and financial costs, could make clinical trials accessible to more people.
“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. For example, patients from UNC Health Pardee in Hendersonville, in the far western reaches of the state, face a nearly four-hour drive to the N.C. Basnight Cancer Hospital — and then the same drive home.
Launching a hybrid decentralized clinical trial model
The two researchers discussed the feasibility of a hybrid decentralized clinical trial model. They envisioned that 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 when expert knowledge of the experimental treatment was needed.
Notably different with the UNC Lineberger model, local hospitals would not be considered regulatorily engaged in research and are not clinical research sites. This allows these trials to be conducted at the local hospitals without the traditional administrative and regulatory burdens associated with site activation—such as contract negotiations, local IRB oversight, and the need for a local site principal investigator with extensive training or regulatory documentation.
“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,” said Lee, a lung cancer expert and a professor of medicine at UNC School of Medicine. “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 FDA’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 hospitals – from UNC Health Blue Ridge in Morganton to UNC Health Rockingham in Eden to Novant Health New Hanover Regional Medical Center in Wilmington — and 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. Two hybrid decentralized trials are currently enrolling patients, with 20 more in various stages of development, review or approval.
Initiative recognition
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 (AACI) Clinical Research Innovation Meeting in Chicago last month.
“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.