Abstract

Clinical trials provide the highest level of evidence in evaluating the safety and efficacy of new radiation approaches for breast cancer. However, there is a significant lack of racial and ethnic diversity among participants who are enrolled. This discrepancy in research inclusion leads to limitations in applying clinical data, therapeutic indices, technique safety, and toxicity to a diverse patient population. A community-based approach, such as the inclusion of community hospitals in trial enrollment, has been shown to boost participation within these underserved populations. The aim of this study was to evaluate the rate of enrollment of racial and ethnic minorities in breast cancer clinical trials with the inclusion of community hospitals within an NYC hospital system. Trial enrollment of breast cancer patients at 3 hospitals was retrospectively assessed. Patient demographics, including age, race, and ethnicity, were compared by enrollment setting. Eligible trials included prospective, randomized clinical trials assessing breast cancer irradiation. Participating hospitals included an academic hospital in Manhattan (MH), and 2 community hospitals in Brooklyn (BH) and Queens (QH). Collectively, these hospitals have a catchment area of 6.2 million, of which 35.2% are White, 19.7% are Asian, 18.3% are Black/African American (B/AA), and 21.2% are Hispanic/Latino (H/L). There is a wide demographic variety within this catchment area. BH serves neighborhoods with a B/AA population as high as 85% and QH serves neighborhoods with an Asian population as high as 54%. From January to December 2022, 146 patients were enrolled in 4 breast cancer trials opened at MH (59.6%, n = 87), BH (28.8%, n = 42), and QH (11.6%, n = 17). The average age was 63.3 (SD = 12.1). Of all patients enrolled, 52.7% identified as White, 23.2% as B/AA, 13% as Asian, and 8.9% as H/L. Of the patients enrolled at MH, 64.4% identified as White, 12.6% as B/AA, 8% as Asian, and 8% as H/L. At BH, 50% identified as B/AA, 38% as White, 4.7% as Asian, and 11.9% as H/L. At QH, 58.8% identified as Asian, 29.4% as White, and 11.8% as B/AA. B/AA (OR = 4.41, 95% CI, 1.94-10.03; p<.01) and Asian (OR = 2.92, 95% CI, 1.07-7.93; p<.05) patients were more likely to be enrolled at a community hospital when compared to an academic hospital. There was no difference in enrollment rates between campuses for H/L patients (OR = 1.29, 95% CI, 0.41-4.06; p = .66). Enrollment of participants from underrepresented racial and ethnic populations in clinical trials is critical to ensuring health equity. These findings suggest partnerships with community hospitals located in underserved populations can be a strategy to improve diversity among clinical trial participants. As it is well-documented that community hospitals can deliver high quality research with similar trial metrics to larger, academic hospitals, partnerships with community hospitals are a feasible way to reduce disparities in breast cancer research.

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