Klein M, Pirzadah H, Magharehabed Y, Chapple A, Nair N, Jernigan A, Castellano T
MS4, The George Washington University School of Medicine and Health Sciences, Washington, DC, United States.
MS3, The Louisiana State University - New Orleans School of Medicine, New Orleans, LA, United States.
Gynecol Oncol Rep. 2024 Dec 3;57:101549. doi: 10.1016/j.gore.2024.101549. eCollection 2025 Feb.
There is no standard clinical trial screening process in gynecologic oncology. In our low resource, highly diverse gynecologic oncology patient population, we sought to create an equitable, adaptable, manual screening process.
Our objective is to describe our clinical trial screening process and success in improving trial enrollment. An Institutional Review Board (IRB) approved quality improvement (QI) project was implemented in July 2022 to evaluate trial access. Screenable events were defined. Potential patients were those with a screenable event: new patients or diagnoses, regimen changes, progressions, and recurrences. Events were categorized into screen positive or screened no trial available. Screen positives were further categorized as screen positive, enrollment failure events or enrollments. Data about patients were collected via weekly research team meetings. Monthly meetings occurred to review progress. The data were compared to trials available, number of patients with trail available, and those that enrolled. Reasons for enrollment fails were tracked.
Over time, "screen no trial available" (SNTA) rates stayed stable, but enrollment rates increased. Patient preference accounted for 32.8 % of enrollment failures (n = 42), pre-existing symptoms 23.4 % (n = 30), and location 21.1 % (n = 27). During increased employee turnover, there was a rise in enrollment fails due to staffing (n = 6, 4.7 %). We describe an effective process of clearly defining and tracking our patient population and 'screenable events' for which all patients are screened and offered trial participation if eligible.
We show that we improved understanding of the patient population, built a clinical trial portfolio better matched to population served, exceeded national averages for enrolling patients on trials, and are improving number eligible.
妇科肿瘤学领域尚无标准的临床试验筛选流程。在我们资源匮乏、患者高度多样化的妇科肿瘤患者群体中，我们试图创建一个公平、可调整的人工筛选流程。
我们的目标是描述我们的临床试验筛选流程以及在提高试验入组率方面的成效。2022年7月实施了一项经机构审查委员会（IRB）批准的质量改进（QI）项目，以评估试验准入情况。定义了可筛选事件。潜在患者是那些出现可筛选事件的患者：新患者或新诊断病例、治疗方案改变、病情进展和复发。事件被分类为筛选阳性或无可用试验筛选。筛选阳性进一步分为筛选阳性、入组失败事件或入组。通过每周的研究团队会议收集患者数据。每月召开会议审查进展情况。将数据与可用试验、有试验可用的患者数量以及入组患者的数据进行比较。跟踪入组失败的原因。
随着时间的推移，“无可用试验筛选”（SNTA）率保持稳定，但入组率有所提高。患者偏好占入组失败原因的32.8%（n = 42），既往症状占23.4%（n = 30），地理位置占21.1%（n = 27）。在员工更替率增加期间，因人员配备导致的入组失败有所增加（n = 6，4.7%）。我们描述了一个有效的流程，即清晰地定义和跟踪我们的患者群体以及“可筛选事件”，对所有患者进行筛选，符合条件者提供试验参与机会。
我们表明，我们提高了对患者群体的了解，建立了更符合所服务人群的临床试验组合，超过了全国试验患者入组平均水平，并且正在增加符合条件的人数。
