BACKGROUND : Clinical trial participation among cancer patients remains low. We sought to examine the impact of patient- and system-level factors on clinical trial participation among gastrointestinal (GI) surgical patients.

STUDY DESIGN : Adult patients with a GI cancer who underwent oncologic surgery who were enrolled in National Cancer Institute (NCI)-funded clinical trials from 2000 through 2019 were compared with trial-eligible adult patients in the National Cancer Database (NCDB) between 2004 and 2017. Multivariable logistic regression was used to identify factors associated with clinical trial participation.

RESULTS : Participants from 36 NCI-funded clinical trials (n = 10,518) were compared with 2,255,730 trial-eligible nonparticipants from the NCDB. Patients aged 65 years or younger (odds ratio [OR] = 0.5, 95% CI 0.47-0.53), Medicare (OR = 0.46, 95% CI 0.43-0.49) or Medicaid (OR = 0.51, 95% CI 0.46-0.58) insurance, as well as lower levels of education (OR = 0.82, 95% CI 0.75-0.89) were associated with a lower likelihood of clinical trial enrollment. Black (OR = 0.72, 95% CI 0.67-0.78) and Asian/Pacific Islander (OR = 0.96, 95% CI 0.85-1.08) patients were less likely to participate in trials vs White patients. There were interactions between race/ethnicity and income; high-income (OR = 0.67, 95% CI 0.55-0.81) and low-income Black (OR = 0.75, 95% CI 0.66-0.87) patients were less likely, respectively, to participate than high- or low-income White individuals (p < 0.001).

CONCLUSIONS : Clinical trial participation is low among adult GI cancer patients who undergo surgery in the US. Programs aimed at improving trial participation among vulnerable populations are needed to improve trial participation.