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

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. (c) 2024 Society for Surgery of the Alimentary Tract. Published by Elsevier Inc. All rights reserved.