BACKGROUND : For results to be generalizable to all cancer patients, clinical trials need to include a diverse patient demographic that is representative of the general population. We sought to characterize the impact of receiving care at a minority-serving hospital (MSH) and/or safety-net hospital on clinical trial enrollment among patients with gastrointestinal (GI) malignancies.

METHODS : Adult patients with GI cancer who underwent oncologic surgery and were enrolled in institutional/National Cancer Institute-funded clinical trials between 2012-2019 were identified in the National Cancer Database. Multivariable regression was used to assess the relationship between MSH and/or safety net status relative to clinical trial enrollment.

RESULTS : Among 1,112,594 patients, 994,598(89.4%) patients were treated at a non-MSH, while 117,996(10.6%) were treated at an MSH. Only 1,857(0.2%) patients were enrolled in a clinical trial; the vast majority received care at a non-MSH (n=1,794, 96.6%). On multivariable analysis, the odds of enrollment in a clinical trial were markedly lower among patients treated at an MSH versus non-MSH. (OR 0.32, 95%CI 0.22-0.46). In addition, even after controlling for receipt of care at MSH, Black patients remained at lower odds of enrollment in a clinical trial versus White patients (OR 0.72, 95%CI 0.53-1.00) (both p<0.05).

CONCLUSIONS : Overall clinical trial participation among patients with GI cancer was extremely low. Patients treated at MSH and high safety-net burden hospitals, as well as Black individuals, were much less likely to be enrolled in a clinical trial. Efforts should be made to improve trial enrollment, as well as address disparities in trial representation.