PENTAGON (Predicting Clinical Trials in Gynecologic Oncology): A Retrospective Study Assessing Study Design Factors...

Objective: Clinical trials are the cornerstone of medical innovation and set the standard for medical care. Cancer clinical trials drive critical innovation and availability of new treatments. However, obstacles to successful recruitment and participation of patients in clinical trials still significantly limit their success. Our objective is to evaluate trial enrollment trends according to both patient and trial demographics/features for those who have sought care at our multi-center, mixed-setting Gynecologic Oncology practice, allowing for us to describe specific trial criteria designs that are negatively associated with diverse enrollment or lack of enrollment completion on cancer clinical trials. Methods: An IRB-approved, retrospective cohort study was completed to evaluate patients who screened positive for a clinical trial through the Gynecologic Oncology practice's manual screening process. We looked at how trial characteristics affect enrollment success. Results: After adjustment, there were no significant differences between patient factors and enrollment status. Higher rates of enrollment were seen among Asian patients and patients whose race was reported as "unknown" (>50%, p = 0.125). There was a drastic, unadjusted estimated increase in enrollment for Medicaid patients compared to patients with other insurance types (55.2% vs. 32%, p = 0.031), but multivariable logistic regression showed that insurance status (Medicaid vs. others) lost significance, p = 0.148. Patients with Stage I cancer accounted for 42.1% of patients enrolled, and enrollment rates were higher than for other cancer stages (p = 0.087). There was a significant increase in enrollment likelihood if the trial did not exclude subjects with prior cancer (50.0% vs. 33.3%, p = 0.046). Conclusions: We demonstrated equitable trial enrollment across different races and insurance statuses and were able to identify criteria that lend itself towards higher rates of enrollment. These findings can be used to tailor cancer trial portfolios to a diverse patient catchment.