Barriers to clinical trial enrollment among gynecologic oncology patients at a National Cancer Institute Comprehensive Cancer Center

Lam, Clarissa Hwu Vanessa Read Susan Zhou Jun-Min Wenham Robert Chon Hye Sook

The objective of this retrospective review was to assess barriers to successful clinical trial enrollment among gynecologic cancer patients at a comprehensive cancer center. A retrospective chart review was performed of all new patients and established patients requiring treatment changes seen in a clinic setting by physicians in the gynecologic oncology department at a national cancer institute between July 1, 2019, and June 30, 2020. Demographic information collected for each patient included age, race, language, distance from the cancer center, insurance type, marital status, education, performance status and medical history. Demographic factors were compared between patients who enrolled in trials and those who were deemed eligible for clinical trials but did not enroll. Patients who did not enroll in a clinical trial were stratified by the reason for not enrolling as physician factor, patient factor, trial factor, and screening failure. Data was collected in a secure REDCap database. Data was analyzed using the Wilcoxon rank sum test and Fisher's exact test. 960 records were reviewed and 165 patients were found to be eligible for a clinical trial at the time of their visit. 35 of these 165 patients (21.2%) enrolled in a clinical trial. Among patients who did not enroll in a clinical trial, the reasons for not doing so were due to a physician factor (71/130 or 55%), patient factor (42/130 or 32%), screening failure (13/130 or 10%), or a trial factor (4/130 or 3%). There were no significant differences in demographics between patients who enrolled in trials and those who did not. Patients who did not enroll secondary to a physician factor differed significantly from those enrolled or attempted to enroll in age and insurance type. Patients who did not enroll secondary to a physician factor were older when compared to those who enrolled or attempted to enroll in a clinical trial but failed the screening process (median of 70 vs 61.5 years old, p=0.014). They were also more likely to have Medicare and less likely to have private insurance (p=0.044). Patients who did not enroll secondary to a patient factor did not appear to differ significantly from patients who did enroll or who failed screening. Although patients who did not enroll secondary to a patient factor lived a mean distance almost twice as far away as those who enrolled or attempted to enroll (mean of 184 vs 91 miles), this was not statistically significant (p=0.107). Based on a one year time span of retrospective review, including the COVID 19 pandemic time, physician factor and concern for a patient's age appears to be the biggest barrier to clinical trial enrollment. Exploring additional reasons behind physicians' reluctance to enroll patients in trials may be the key to increasing clinical trial enrollment of eligible patients. [ABSTRACT FROM AUTHOR] Copyright of Gynecologic Oncology is the property of Academic Press Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)