Healthcare disparities are associated with eligibility and enrollment in clinical trials in Louisiana.

Abstract

e13728 Background: Clinical trials offer an opportunity to evaluate novel therapeutic strategies and modalities of care. Overall enrollment is low for clinical trials, but previous literature has highlighted lower rates of enrollment among underrepresented populations. A disproportionately low accrual of minority or other populations will result in reducing the ability of such clinical trials to prove general benefit to the overall population. This study aims to evaluate the population of those able or unable to qualify for and enroll in the Gulf South Clinical Trials network, a minority/underserved NCORP community site. Methods: Patient data was collected through interviews using a screening tool developed by the National Cancer Institute’s Community Oncology and Prevention Trials Research Group and active enrollment of ongoing clinical trials. Patients were interviewed regarding demographic data and tumor staging. Reason for ineligibility or non-enrollment was documented by the clinical staff. Clinical trials were categorized between Cancer-Control and Cancer Care Delivery Research (CC-CCDR) Trials and Cancer Treatment Trials from 2017 and 2023. Rates of eligibility and enrollment were compared via Fisher’s Exact tests. Results: CC-CCDR Trials had 363 participants while Cancer Treatment had 550 participants. CC-CCDR Trials resulted in 19% (n=69) of patients being ineligible with 81% (n=294) being eligible with a higher proportion of Whites (p<.001), non-rural (p = .021), low income (p=.007), private insurance (p=<.001), stage 1 tumors (p<.001), and having a genetic predisposition (p<.001) being ineligible. From the patients that were eligible, 13% (n= 39) of patients were not enrolled with 87% (n=255) of patients enrolled. Cancer Treatment Trials resulted in 23% (n=129) of ineligible patients and 76.5% (n=421) of eligible patients, with a higher proportion of low income (p=.002), private insurance (p=.035), and those not having genetic predispositions (p=.022) being ineligible. From the participants that were eligible, 20% (n=85) of patients were not enrolled with 80% (n=336) of patients enrolled, with a higher proportion of female (p= .002) patients not enrolled. Conclusions: Disparities in socioeconomic factors and female gender are associated with lower rates of eligibility and enrollment in clinical trials in community oncology settings. Future research identifying modifiable underlying factors can assist in developing strategies to improve enrollment in underserved populations.