Investigating potential disparities in clinical trial eligibility, offers and enrollment at an NCI-designated comprehensive cancer center.

Abstract

e19076 Background: Although many prior studies have demonstrated the existence of disparities in cancer clinical trial enrollment, few studies have explored clinical trial eligibility criteria and offers as potential drivers of disparities in enrollment. Methods: We identified patients age 18-96 with gastrointestinal (GI) cancers who were seen as new patients at the University of Michigan in 2016. Primary outcomes were: 1) Eligibility for; 2) Offer of; and 3) Enrollment in, a clinical trial. All 28 clinical trials available in 2016 for patients with GI cancers were considered. We assessed individual patient eligibility for any trial by exhaustive review of the electronic medical record (EMR). We determined trial offers and patient enrollment in a trial by EMR review, including notes by clinicians and research coordinators. Independent variables included clinical and non-clinical patient-related factors (such as age, race, and gender) as well as provider-related factors. We assessed associations between patient- and provider-related factors and our primary outcomes, using multivariable regression. Results: Of 827 patients, 40% were female, 18% were age ≥75, 7% were Black, and 2% were Asian. 155 (19%) patients were potentially eligible for an open clinical trial. Among patients potentially eligible for a trial, 83 (54%) had documentation of a trial being offered and 46 (30%) enrolled. After adjustment, age < 75, lower Charlson comorbidity index, not having a second primary cancer, hepatobiliary primary, and higher disease stage were associated with a higher odds of clinical trial eligibility (all P < 0.05). Having ≥1 child, lower Charlson comorbidity index, hepatobiliary primary, and higher disease stage were associated with a higher odds of being offered a clinical trial (all P < 0.05). Hepatobiliary primary and higher disease stage were associated with a higher odds of enrollment (all P < 0.05). Conclusions: We found that patients age 75 or over were less likely to be eligible for a clinical trial, but did not find significant disparities in eligibility by other non-clinical factors such as gender and race. Only 54% of patients potentially eligible for a trial had documentation of a trial being offered; this varied by number of children, but not by any other non-clinical factors. We found no significant associations between non-clinical factors and enrollment. Future work is needed to ensure that eligibility criteria for clinical trials reflect the overall patient population, and that trials are offered to eligible patients.