National enrollment of lung cancer clinical trials is disproportionate based on race and health care access

Abstract

Objective: Despite declining lung cancer mortality in the United States, survival differences remain among racial and ethnic minorities in addition to those with limited health care access. Improvements in lung cancer treatment can be obtained through clinical trials, yet there are disparities in clinical trial enrollment of other cancer types. This study aims to evaluate disparities in lung cancer clinical trial enrollment to inform future enrollment initiatives.

Methods: We analyzed patients with non-small cell lung cancer from the National Cancer Database (2004-2018), categorizing them as enrolled or not enrolled in clinical trials based on "rx_summ_other" data element. Clinical, demographic, and institutional factors associated with trial enrollment were assessed using bivariate and multivariate analysis, adjusting for institutional-level clustering.

Results: A total of 1924 (0.12%) patients with lung cancer were enrolled in clinical trials. Enrolled patients were predominantly non-Hispanic White (82%), with greater socioeconomic status, treated at academic programs (67%), and had private insurance (42%) or Medicare (44%). They also traveled further for treatment compared with unenrolled patients (56 vs 27 miles, P < .001). After adjusting for demographic and clinical factors, lung cancer trial enrollment was significantly less likely among Black (odds ratio, 0.55; 95% confidence interval, 0.5-0.7, P < .001) and Hispanic (0.66; 95% confidence interval, 0.5-0.9, P = .01) patients. Patients with Medicaid or uninsured, in the lowest socioeconomic status group, and those treated at community-based cancer programs were the least likely to enroll.

Conclusions: Enrollment in lung cancer trials disproportionally excludes minority patients, those in the lowest socioeconomic status, community cancer programs, and the underinsured. These disparities in demographic and access for trial participation show a need for improved enrollment strategies.

Keywords: clinical trial enrollment; health care access; lung cancer; racial and ethnic minority; racial disparities; socioeconomic status.