Disparities in clinical trial enrollment among patients with gastrointestinal cancer relative to minority-serving and safety-netting hospitals

Abstract

Background: For results to be generalizable to all patients with cancer, clinical trials need to include a diverse patient demographic that is representative of the general population. We sought to characterize the effect 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 and 2019 were identified in the National Cancer Database. Multivariable regression was used to assess the relationship between MSH and safety-net status relative to clinical trial enrollment.

Results: Among 1,112,594 patients, 994,598 (89.4%) were treated at a non-MSH, whereas 117,996 (10.6%) were treated at an MSH. Only 1857 patients (0.2%) were enrolled in a clinical trial; most patients received care at a non-MSH (1794 [96.6%]). On multivariable analysis, the odds of enrollment in a clinical trial were markedly lower among patients treated at an MSH vs non-MSH (odds ratio [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 than White patients (OR, 0.57; 95% CI, 0.45-0.73; both P < .05).

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

Keywords: Clinical trial enrollment; Disparities; Gastrointestinal cancer; Minority-serving hospitals; Safety-net hospitals.