Addressing Racial and Ethnic Disparities in Cancer Clinical Trial Access

Despite advancements in research, racial and ethnic inequities continue to occur in cancer clinical trial participation, exacerbating disparities in access to investigational therapies. A recent study published in JNCI Cancer Spectrum explored how social determinants of health (SDOH) contribute to these inequities.

“Here, we aimed to quantify racial and ethnic inequities in clinical trial participation among patients with 22 common cancers and evaluate which area-level SDOH factors mediate observed inequities using a contemporary nationwide electronic health record (EHR) database,” the researchers stated.

The study, a retrospective analysis of electronic health records (EHR) from 2011 to 2023 combined with neighborhood-level SDOH data, examined clinical trial participation among 250 105 patients with 22 common cancers. Participation rates were 6.3% for White patients, 3.7% for Black patients, and 4.4% for Latinx patients. These inequities persisted across nearly all cancer types examined and were consistent over the 12-year study period.

Black and Latinx patients were more likely to reside in economically and socially marginalized neighborhood characterized by residential segregation, low vehicle ownership, and limited English proficiency. Residential segregation was the most significant barrier, accounting for approximately 30% to 40% of the inequities between Black and White patients and between Latinx and White patients. These structural barriers significantly hindered access to and participation in clinical trials.

The researchers noted that these findings underscore the urgent need to address structural and practical barriers to trial participation to improve racial and ethnic diversity in clinical trials. Without targeted interventions, clinical trials risk perpetuating inequities in cancer outcomes and producing findings that are not generalizable to diverse patient populations.

Recent legislative efforts, including the Food and Drug Omnibus Reform Act of 2022, emphasize the importance of diversity in clinical trials. Effective in 2024, the Act mandates that drug sponsors submit diversity plans to the US Food and Drug Administration (FDA), outlining strategies to ensure trials reflect the demographics of intended patient populations. The researchers also suggested measures such as providing transportation support, recruiting multilingual staff, translating materials, and expanding trial recruitment to community-based cancer centers as additional ways to mitigate gaps in clinical trial access.

“These findings can inform targeted efforts to increase racial and ethnic diversity in cancer trials,” the researchers concluded. “Without focused policy and operational efforts to increase clinical trial participation among racially and ethnically diverse patient populations, trials may perpetuate inequities in investigational drug access and generate findings that are not generalizable to real-world patients with cancer.”

Reference

Guadamuz JS, Wang X, Altomare I, et al. Mediators of racial and ethnic inequities in clinical trial participation among patients with cancer, 2011-2023. JNCI Cancer Spectr. 2024;8(5):pkae085. doi:10.1093/jncics/pkae085