| Sumario: | Simple Summary: Clinical trials are a crucial part of healthcare because they can be used to find new and advanced treatments for patients. However, trials are significantly limited due to the lack of enrollment by participants, especially those of diverse backgrounds. In our paper, we analyzed gynecologic cancer trials, and factors that increased or limited patient participation. We analyzed factors, such as insurance type, race, and cancer stage, and how they might affect whether a patient successfully enrolled in a trial. We found that patients with Medicaid insurance and those with Stage I cancer were more likely to enroll. Race and insurance type also played a role, but some differences were not significant after adjusting for other factors. Additionally, trials that did not exclude patients with a history of prior cancer had higher enrollment rates. Our study signifies that certain factors can enhance enrollment and lead to clinical trial success. This finding can be helpful for researchers in the future, because they can model clinical trials to include factors that maximize participation. 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.
|
|---|