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.
目的：临床试验是医学创新的基石，并为医疗实践设定标准。肿瘤临床试验推动关键创新及新疗法的可及性。然而，患者成功入组和参与临床试验的障碍仍显著限制其成功率。本研究旨在基于患者及试验的人口学特征/设计特点，评估在我们多中心、混合型妇科肿瘤诊疗机构寻求治疗的患者临床试验入组趋势，从而识别与入组多样性不足或未能完成入组相关的特定试验设计标准。 方法：完成一项经机构审查委员会批准的回顾性队列研究，评估通过妇科肿瘤诊疗机构人工筛选流程初筛阳性的临床试验患者。我们分析了试验特征如何影响入组成功率。 结果：经校正后，患者因素与入组状态间无显著差异。亚裔患者及种族记录为“未知”的患者显示出更高的入组率（>50%，p=0.125）。医疗补助保险患者相较于其他保险类型患者的入组率存在未经校正的显著预估增长（55.2% vs. 32%，p=0.031），但多变量逻辑回归显示保险状态（医疗补助保险 vs. 其他）的显著性消失（p=0.148）。I期癌症患者占入组患者的42.1%，其入组率高于其他分期患者（p=0.087）。若试验未排除有癌症病史的受试者，入组可能性显著增加（50.0% vs. 33.3%，p=0.046）。 结论：本研究证实了不同种族和保险状态患者间的公平入组，并识别出有助于提高入组率的设计标准。这些发现可用于针对多样化患者群体优化肿瘤临床试验组合设计。
肿瘤(癌症)患者之家