Increased racial and ethnic groups representation in clinical trials in a demographically diverse population.

Abstract

e13782 Background: Florida has a diverse population, with Hispanics (of all races) becoming the largest subpopulation after White non-Hispanics. Cleveland Clinic Florida (CCF) supports this community through culturally tailored programs to boost clinical trial participation, including e-consent forms, cultural competence training for healthcare providers, easy access to interpreters, a diverse staff, and culturally relevant materials. This analysis evaluates the enrollment of ethnically and racially diverse groups in cancer clinical trials at a multi-site institution in Florida whether it reflects the patient population demographics in a muti-site institution in the state of Florida. Methods: CCF database was retrospectively reviewed for cancer patients enrolled on clinical trials at CCF. Patients residing in Florida were included if diagnosed with any cancer and/or treated for it at one of CCF’s 3 cancer centers distributed throughout Florida between 2020-2023 (inclusive). Data on demographic variables were collected including age, race-ethnicity, sex, insurance type, socioeconomic status (which was estimated through the Area Deprivation Index), marital status, preferred language, and distance to center. Similarly, data was collected on clinical variables like primary site of cancer, staging, treatment modality, family history, comorbidities, and ECOG score. Data was collected on general population of patients seeking medical care at the same centers during that period for comparison (N = 9059). Descriptive analysis was then performed using SAS and R. Results: N = 484 eligible patients were included in the analysis. Median age was 67.2 years old (57.0 – 75.0). The most common race/ethnicity was White non-Hispanics (52.3%) followed by White Hispanics (19.2%). The most common cancer was Hematologic malignancies (43.6%) followed by Breast (37.2%) reflecting the clinical trials available. Females were 65.1% vs. 34.9% males which reflect the large percentage of breast cancer patients. In comparison to the general patient population, there were similar trends among the racial/ethnic groups distribution. Hispanics of all races consisted 25.6% of the enrolled patients which is proportionate to the general population (24.5%). There were similar proportions of White non-Hispanics (52.3% vs. 54.1%) and Black non-Hispanics (15.7% vs. 16.4%) in the study when compared to the general population. There was a slightly higher proportion of Asians (3.7% vs. 2.7%). Conclusions: This analysis highlights the potential to increase enrollment of minority groups, often underrepresented in oncology trials, through cancer research programs that use culturally appropriate, patient-centered practices. Improving racial/ethnic representation in clinical trials is crucial for reducing confounding variables, enhancing the generalizability of results, and addressing healthcare disparities.