National Cancer Institute, Bethesda; SAIC-Frederick, Frederick National Laboratory for Cancer Research, Frederick; The EMMES Corporation, Rockville, MD; St Joseph Hospital of Orange, Orange, CA; Billings Clinic Cancer Center, Billings, MT; Gundersen Health System, La Crosse; Waukesha Memorial Hospital (ProHealth Care), Waukesha, WI; The Cancer Program of Our Lady of the Lake and Mary Bird Perkins Cancer Center, Baton Rouge, LA; Delaware Cancer Consortium, Dover; Helen F. Graham Cancer Center, Newark, DE.
J Oncol Pract. 2014 Mar;10(2):e73-80. doi: 10.1200/JOP.2013.001194. Epub 2014 Jan 14.
Screening logs have the potential to help oncology clinical trial programs at the site level, as well as trial leaders, address enrollment in real time. Such an approach could be especially helpful in improving representation of racial/ethnic minority and other underrepresented populations in clinical trials.
The National Cancer Institute Community Cancer Centers Program (NCCCP) developed a screening log. Log data collected from March 2009 through May 2012 were analyzed for number of patients screened versus enrolled, including for demographic subgroups; screening methods; and enrollment barriers, including reasons for ineligibility and provider and patient reasons for declining to offer or participate in a trial. User feedback was obtained to better understand perceptions of log utility.
Of 4,483 patients screened, 18.4% enrolled onto NCCCP log trials. Reasons for nonenrollment were ineligibility (51.6%), patient declined (25.8%), physician declined (15.6%), urgent need for treatment (6.6%), and trial suspension (0.4%). Major reasons for patients declining were no desire to participate in trials (43.2%) and preference for standard of care (39%). Major reasons for physicians declining to offer trials were preference for standard of care (53%) and concerns about tolerability (29.3%). Enrollment rates onto log trials did not differ between white and black (P = .15) or between Hispanic and non-Hispanic patients (P = .73). Other races had lower enrollment rates than whites and blacks. Sites valued the ready access to log data on enrollment barriers, with some sites changing practices to address those barriers.
Use of screening logs to document enrollment barriers at the local level can facilitate development of strategies to enhance clinical trial accrual.
筛选日志有可能帮助肿瘤学临床试验项目的现场层面，以及试验领导者，实时解决入组问题。这种方法在改善临床试验中种族/少数民族和其他代表性不足人群的代表性方面可能特别有帮助。
美国国家癌症研究所社区癌症中心计划（NCCCP）开发了筛选日志。对 2009 年 3 月至 2012 年 5 月期间收集的日志数据进行了分析，比较了筛选和入组的患者数量，包括人口统计学亚组、筛选方法以及入组障碍，包括不合格的原因以及提供者和患者拒绝提供或参与试验的原因。获得用户反馈，以更好地了解日志的实用性。
在 4483 名接受筛查的患者中，有 18.4%入组到 NCCCP 日志试验中。未入组的原因包括不合格（51.6%）、患者拒绝（25.8%）、医生拒绝（15.6%）、急需治疗（6.6%）和试验暂停（0.4%）。患者拒绝的主要原因是没有参与试验的意愿（43.2%）和偏好标准治疗（39%）。医生拒绝提供试验的主要原因是偏好标准治疗（53%）和对耐受性的担忧（29.3%）。日志试验的入组率在白人和黑人之间（P =.15）或西班牙裔和非西班牙裔患者之间（P =.73）没有差异。其他种族的入组率低于白人和黑种人。各站点都非常重视对入组障碍的日志数据的便捷访问，一些站点改变了实践以解决这些障碍。
在地方层面使用筛选日志记录入组障碍可以促进制定策略来增加临床试验的入组率。
