Making Clinical Trials More Accessible to Underserved Populations

Researchers Aim to Bring Life-Changing Cancer Therapies to All

A medical professional going over medication with an older lady.

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’s CATCH-UP (Create Access to Targeted Cancer Therapy for Underserved Populations) grant is providing congressionally mandated funding to help address disparities in clinical trial enrollment that have existed for decades. Institutions that receive the 1-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.”

Exceeding Goals

The Cancer Center, one of only 8 NCI-designated cancer centers in the US 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.

Cancer Center researchers selected 17 ETCTN clinical trials to offer to cancer patients. While the grant required institutions to enroll at least 24 patients in ETCTN trials during the first year, Wake Forest Baptist researchers went further 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.

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 Dr. 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 Dr. 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 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.

“In addition to addressing social needs, these navigators promote participation in cancer research studies to their patients,” said Ronny Bell, PhD, MS, professor of social sciences and health policy, who directs the Cancer Center’s Office of Cancer Health Equity. “Because they work with these communities every day and understand their needs and concerns, we’ve seen a very big increase in cancer study participation from underserved groups since we’ve had this program.”

Another Cancer Center program, called Advocates of Research and Medicine, trains cancer survivor volunteers to be advocates for cancer research by teaching them about cancer research and the importance of having all groups represented in these studies. The CATCH-UP grant researchers also designated specific disease-orientated team champions to review clinical trials and evaluate progress.

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.