Abstract
Abstract Background: Phase 1 clinical trials offer a novel therapeutic option to individuals who have progressed past standard of care treatment and valuable data oncological field advancement. Previous research has shown that a significant proportion of patients referred for clinical trials do not meet eligibility criteria and are considered screen failure (SF) after consenting and even more patients referred are pre-screen failure before consenting (PSF). In addition, historically, the rate of clinical trial enrollment has been low in underrepresented minorities. These SF rates and disparities could have further increased due to COVID challenges. In this study, we aim to define the most common reasons for SF and study disparities in trial enrollment demographics in the post-COVID period. Methods: A cross-sectional sample of patients referred to the Sylvester Comprehensive Cancer Center Phase I Clinic during the pre-COVID period (11/2018-12/2019) and post-COVID period (11/2021-12/2022) was analyzed. Patients’ demographics, malignancies and SF patterns were analyzed. Reasons for SF were categorized as: cancer progression, clinical trial ineligibility, lack of applicable trial, system delays due to staffing, patient hesitancy/refusal or loss to follow-up. Chi square tests were then used to analyze the SF rate based on patient demographics. Results: During the pre-COVID period, 98 patients consented and 75 enrolled with a screen failure of 21.4%, compared to the post-COVID period when 101 patients consented and 74 enrolled with a screen failure of 27.7%. During the post-COVID period, 69 patients were PSFs, and 4 patients waitlisted and never consented. Of the PSF (n=69), 37 (55%) were female, 27 (40%) were Hispanic, 10 (15%) were Black, and 1 (1%) was Asian. The majority of PSFs were patients with thoracic cancer (45.5%), followed by GI (19%) and GYN malignancies (16.1%). The main reasons endorsed for PSFs were patients refusal/loss to follow up (35%), not consented due to system delays (20.5%), cancer progression (20.5%), trial ineligibility (17%), and lack of applicable trial (7%). When using chi square tests to analyze the prescreen failure vs. enrollment rate based on patient demographics, there was no statistically significant difference between race (p=0.19), ethnicity (p=0.45), or gender (p=0.22). Conclusion: Though the number of patients enrolled in the pre- and post-COVID period was similar, the rate of screen and prescreen failures differed. Trial design ineligibility, patient hesitancy/loss to follow up, and systemic challenges due to staff shortages contributed to SFs in the post COVID period. Staff shortages after the COVID-19 pandemic affected Phase 1 trial enrollment but was not the predominant SF reason. Studies to address clinical trial complexity and issues of patient hesitancy and withdrawal from clinical trial process are needed. The lack of demographic disparities in enrollment and SFs suggest that these system issues did not disproportionately affect any demographic group in this diverse cohort. Citation Format: Sapna A. Kedia, Rakhi Modak, Nora A. El-Abbar, Jaime R. Merchan, Estelamari Rodriguez. Understanding disparities in clinical trial enrollment: A study of screen failures to phase I clinical trials in a minority-serving institution in the post-COVID period [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr B040.
