An Argument for Decentralized Clinical Trials in Gynecologic Oncology

Abstract

To evaluate factors that may influence clinical trial enrollment, we compared demographics, clinical characteristics, and patient-reported social determinants of health for patients with advanced ovarian cancer who were approached for enrollment in a prehabilitation trial. Although no significant differences were found in the majority of demographic and clinical characteristics, distance to study institution was associated with decision to enroll; 21.9% of enrolled compared with 42.2% of not enrolled patients lived 200 miles or more from the study institution (P< .05). In addition, compared with not enrolled patients, enrolled patients were more likely to be receiving neoadjuvant chemotherapy within the study institution compared with a nonstudy institution clinician (81.2% vs 53.1%, P=.02). These findings highlight barriers to enrollment that can be addressed through decentralization of clinical trials.