Barriers to enrollment in clinical trials in gynecologic oncology.
Authors: McMinn Erin , Smith Anna Jo Bodurtha , Arasappan Dhivya , Koelper Nathanael , Simpkins Fiona , Howell Elizabeth A , Ko Emily Meichun 
Published: May 2024

e13511

Background: While clinical trials improve survival in gynecologic oncology, racial and ethnic minorities remain underrepresented. Our objective was to evaluate factors associated with enrollment among patients considered for trials at a tertiary care center to inform future participant recruitment. Methods: We conducted a retrospective cohort study at the University of Pennsylvania Health System from 1/1/2022-12/31/2022. Our primary objective was the referral rate to clinical trials of patients discussed at a weekly multi-disciplinary tumor board. Patients could be discussed more than once and referred for screening for multiple trials. Each contact was classified as ‘referred/not referred’ for trial(s) screening and ‘enrolled/not-enrolled’ on trial(s). We collected socio-demographic, cancer, trial screening, and enrollment data, including reasons for ineligibility or non-enrollment, from electronic health records. We compared patient factors across 3 subgroups: 1) not-referred, 2) referred not-enrolled, 3) referred and enrolled. We performed descriptive analyses to characterize patient cohorts. Results: In a one-year period, 264 patients—194 unique—were discussed at tumor board. Referral rate for trial screening was 57%, representing 135 trial referrals for 111 unique patients. Patients were referred to screening for 2.2 trials on average. The median age of patients discussed was 65 years (IQR 58-73 years). 65.0% self-identified as White, 24.7% Black, and 10.3% other race. 96% identified English as their preferred language. The majority had Medicare insurance (51.0%), followed by private insurance (32.5%), and Medicaid (14.4%). Of 111 patients referred for trial screening, 12 patients enrolled in a trial for a referral-to-enrollment rate of 10.8% (12/111) and an overall enrollment rate of 6.2%. The majority of enrolled patients were white (10/12) and had Medicare (66%) or private insurance (25%). Cancer type varied by referral status, with most referrals for ovarian (n=87, 64%) and uterine cancer (n=37, 27.4%) and 5 for cervical cancer (3.7%). The non-referred cohort had lower rates of ovarian cancer (49.6%) and higher rates of cervical (12.4%) and other cancers (14.0%). Of patients referred to trial, but not enrolled, only 33.7% had a documented reason for non-enrollment. Documentation for incomplete screening or ineligibility cited the patient opting out of screening (26), medical comorbidity (22), and pursuit of other trial (16). Conclusions: While 57% of tumor board patients were referred for screening for at least one clinical trial, only 10.8% of referred patients and 6.2% of patients overall were enrolled in a trial. Disparities by race and insurance type were apparent between patients enrolled and not enrolled on trial. Improving documentation, educating patients about trials early in their disease course, and less restrictive trial criteria may help improve minority enrollment rates in clinical trials.