Making Clinical Trials More Accessible to Underserved Populations

With funding from the National Cancer Institute (NCI), researchers at Atrium Health Wake Forest Baptist Medical Center’s Comprehensive Cancer Center are making it easier for racial and ethnic minorities and underserved patients in North Carolina, Virginia and West Virginia to access the latest cancer treatments through clinical trials.

The NCI grant entitled CATCH-UP (Create Access to Targeted Cancer Therapy for Underserved Populations) is congressionally mandated funding to help address disparities in clinical trial enrollment that have existed for decades. Institutions that receive the one-year grant can participate in trials of potentially life-changing targeted cancer therapies administered by the NCI’s Experimental Therapeutics Clinical Trials Network (ETCTN).

“The ultimate goal of conducting clinical trials is to find better therapies for cancer,” said Alexandra Thomas, MD, Williams Family Chair in Breast Oncology and Professor of Hematology and Oncology, who leads the project at the Cancer Center. “But those trials aren't going to work if the patients enrolling in the trials don't match the populations we ultimately treat with these therapies.”

"The ultimate goal of conducting clinical trials is to find better therapies for cancer, but those trials aren't going to work if the patients enrolling in the trials don't match the populations we ultimately treat with these therapies." - Alexandra Thomas, MD

Exceeding goals

Wake Forest Baptist’s Comprehensive Cancer Center, one of only eight NCI-designated cancer centers in the U.S. to receive a CATCH-UP award, used the grant to boost enrollment of minority and underserved populations by bringing clinical trials closer to where people live and addressing barriers that may prevent participation.

“The CATCH-UP grant aligns with the Cancer Center’s commitment to improve cancer outcomes for all patients,” Thomas said. “It gave us the resources to buttress some of the efforts already in place to focus on diversifying the patients enrolled in these trials.”

Cancer Center researchers selected 17 ETCTN clinical trials to offer to cancer patients. While the CATCH-UP grant required institutions to enroll at least 24 patients in ETCTN trials during the first year, Wake Forest Baptist researchers went above and beyond by accruing 33 patients, 14 of whom were from underserved populations.

“This grant helped give us a purposeful goal to reach more underserved populations by intentionally working toward tackling barriers,” said Jimmy Ruiz, MD, Associate Professor of Hematology and Oncology, co-principal investigator for the project and assistant director for clinical research at the Cancer Center. “It also showed us that we can meet the needs of our diverse communities by encouraging and educating them on the importance of clinical trials .”

Location is key

Clinical trial location was one important barrier that the researchers addressed through this grant.

“People in underserved populations often live some distance away from our Cancer Center, and clinical trials typically require more clinical visits than traditional therapies,” said Ruiz. “This can create a significant barrier for clinical trial participation.”

Instead of having patients come to the Cancer Center in Winston-Salem, the researchers worked to implement clinical trials in community-based practices that served minority and underserved populations. In some cases, this meant co-managing patients.

For example, one of Thomas’ patients came to see her in Winston-Salem when starting a new clinical study and then went to a doctor closer to home for the rest of her visits. “This co-management setup not only gave this patient access to a clinical trial she otherwise wouldn’t have been able to participate in, but also allowed her the convenience of staying closer to home during much of her treatment,” explained Thomas.

Building trust

Cultural barriers that affect participation in a clinical trial can be complex, so it often takes a personal approach to build trust and fill in knowledge gaps about how trials work. To do this, the researchers drew on several programs already in place at the Cancer Center. One is the Center’s Population Health Navigator Program, which uses culturally and linguistically concordant navigators to address the social needs of cancer patients. There are specific navigators for African American, Hispanic and rural patients.

The Cancer Center also has a program called Advocates of Research and Medicine that trains cancer survivor volunteers to be advocates for cancer research by teaching them about cancer research and the importance that all groups are represented in these studies. These advocates provide another resource to patients who might be considering a cancer trial.

The CATCH-UP grant researchers also designated specific disease-orientated team champions to review clinical trials and evaluate progress in accruing minority and underserved populations.

Looking to the future

“The CATCH-UP study required a direct investment in working to understand why we have a deficit in representation in trials,” said Bell. “We plan to make sure that what we learn gets incorporated into the strategy that we use in the future for recruitment and retention in cancer therapy trials.”

Some of the new knowledge is already being implemented. For example, clinical trials outside of the ETCTN network are now increasingly being offered at community-based practices. Many of the studies that were initially made available through the CATCH-UP grant are also still enrolling patients thanks to funding from the Cancer Center.

Bell adds that as the Cancer Center integrates with the Atrium Health enterprise, it will open even more opportunities to address disparities.

“Atrium Health’s Levine Cancer Institute reaches a large number of patients, including a very large urban area in Charlotte,” said Bell. “We will continue to think about ways to continue our efforts to diversify our clinical trial offerings, keeping in mind this new strategic alliance.”