e13524 Background: Clinical trials are critical to advancing cancer care, yet enrollment remains low, with only 7.1% of adults with cancer enrolling in treatment trials nationally. We sought to characterize reasons for non-enrollment among patients screened for clinical trial participation at two VA Medical Centers, where Veterans often present with higher comorbidity burden that may disproportionately affect trial eligibility. Methods: We conducted a retrospective chart review of 76 consecutive Veterans screened for eligibility in oncology clinical trials for lung and esophageal cancers between 2021 and 2025 at the Ann Arbor and Cleveland VA Medical Centers. Demographic, disease-related, and trial-related factors were abstracted. Reasons for non-enrollment were categorized into predefined domains and descriptive statistics were used to summarize findings. Patients with multiple reasons for non-enrollment were categorized by the primary limiting factor. Results: Of 76 patients screened, 70 were ultimately not enrolled in a clinical trial, corresponding to a screen failure rate of 92.1%. Trial ineligibility at the time of screening accounted for 77% of non-enrollment cases (54/70). Among trial ineligible patients, the most frequent barrier was mismatch between disease characteristics and restrictive trial inclusion criteria (n = 34), followed by prior therapy that precluded eligibility (n = 20), and medical comorbidity (n = 3). Patient-related factors accounted for 13 cases of non-enrollment, most commonly preference for standard-of-care treatment and patient hesitation. Overall, non-enrollment was driven predominantly by trial-related eligibility constraints rather than patient refusal. Multiple concurrent barriers to enrollment were common; however, restrictive trial inclusion criteria were most often identified as the primary limiting factor. Conclusions: We highlight a critical misalignment between contemporary clinical trial eligibility criteria and the clinical realities of Veterans with aerodigestive cancers. Earlier trial referral and the availability of more pragmatic trial designs are essential to improve trial access and equity for Veteran populations. Clinical trial screening and enrollment outcomes. Category Number of Patients % of Total Patients Screened Total Patients Screened 76 100% Enrolled on any clinical trial 6 7.9% Not Enrolled 70 92.1% Mismatch between Disease Characteristics and Inclusion Criteria 34 44.7% Prior Therapy precluded inclusion 20 26.3% Medical Comorbidity 3 3.9% Patient Preference for SOC 13 17.1%
Kelekar et al. (Thu,) studied this question.