Department of Radiation Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
Clin Trials. 2009 Dec;6(6):610-7. doi: 10.1177/1740774509348526. Epub 2009 Nov 23.
To assess cancer clinical trial recruitment and reasons for nonaccrual among a rural, medically underserved population served by a community-based cancer care center.
We prospectively tracked clinical trial enrollment incidence among all new patients presenting at the Rapid City Regional Cancer Care Institute. Evaluating physicians completed questionnaires for each patient regarding clinical trial enrollment status and primary reasons for nonenrollment. Patients who identified as American Indian were referred to a program where patients were assisted in navigating the medical system by trained, culturally competent staff.
Between September 2006 and January 2008, 891 new cancer patients were evaluated. Seventy-eight patients (9%; 95% confidence intervals, 7-11%) were enrolled on a clinical treatment trial. For 73% (95% confidence intervals, 69-75%) of patients (646 of 891) lack of relevant protocol availability or protocol inclusion criteria restrictiveness was the reason for nonenrollment. Only 45 (5%; 95% confidence intervals, 4-7%) patients refused enrollment on a trial. Of the 78 enrolled on a trial, 6 (8%; 95% confidence intervals, 3-16%) were American Indian. Three additional American Indian patients were enrolled under a nontreatment cancer control trial, bringing the total percentage enrolled of the 94 American Indians who presented to the clinic to 10% (95% confidence intervals, 5-17%).
Eligibility rates were unable to be calculated and cross validation of the number in the cohort via registries or ICD-9 codes was not performed.
Clinical trial participation in this medically underserved population was low overall, but approximately 3-fold higher than reported national accrual rates. Lack of availability of protocols for common cancer sites as well as stringent protocol inclusion criteria were the primary obstacles to clinical trial enrollment. Targeted interventions using a Patient Navigation program were used to engage AI patients and may have resulted in higher clinical trial enrollment among this racial/ethnic group.
评估在一家社区癌症护理中心服务的农村医疗服务不足人群中的癌症临床试验招募情况和未入组的原因。
我们前瞻性地跟踪了 Rapid City Regional Cancer Care Institute 新就诊患者的临床试验入组发生率。评估医生为每位患者填写了临床试验入组状态和未入组的主要原因的调查问卷。被确定为美国印第安人的患者被转介到一个项目中，该项目由经过培训、文化能力强的工作人员协助患者了解医疗系统。
在 2006 年 9 月至 2008 年 1 月期间，共评估了 891 例新发癌症患者。78 例患者（9%；95%置信区间，7-11%）参加了临床治疗试验。对于 73%（95%置信区间，69-75%）（891 例患者中的 646 例）的患者，缺乏相关的方案可用性或方案纳入标准的严格性是未入组的原因。只有 45 例（5%；95%置信区间，4-7%）患者拒绝参加试验。在入组试验的 78 例患者中，有 6 例（8%；95%置信区间，3-16%）为美国印第安人。另有 3 名美国印第安人参加了非治疗性癌症控制试验，使在诊所就诊的 94 名美国印第安人中入组试验的总比例达到 10%（95%置信区间，5-17%）。
无法计算入组率，也未通过注册表或 ICD-9 代码对队列中的人数进行交叉验证。
总体而言，该医疗服务不足人群的临床试验参与率较低，但略高于全国报告的入组率。常见癌症部位的方案缺乏以及严格的方案纳入标准是临床试验入组的主要障碍。使用患者导航计划进行有针对性的干预措施，使这一种族/民族群体的临床试验入组率提高。
