Use of a clinical trial screening tool to enhance patient accrual
Use of a clinical trial screening tool to enhance patient accrual
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DOI：
10.1002/cncr.33399
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发表时间：
2021-02-19
期刊：
影响因子：
6.2
通讯作者：
McCaskill-Stevens, Worta
中科院分区：
文献类型：
--
作者：
St Germain, Diane C.;McCaskill-Stevens, Worta
背景：尽管存在多个医生、患者和系统障碍，但临床试验患者招募仍然具有挑战性。扩大收集人口统计数据，包括社会经济状况（就业，收入，教育）和合并症，可以提高我们对已确定的障碍的理解，为制定干预措施以克服这些障碍提供信息，并认识到它们对治疗结果的影响。开发了一种临床试验筛选工具，以收集扩大的人口统计学数据和试验入组障碍;该工具已在国家癌症研究所临床肿瘤学研究计划中实施。这篇文章的目的是描述的开发和实施的工具，并分享在其use.Methods的前43个月获得的信息，有19,373个条目收集，74%的筛选参加了临床试验。比较筛选和入组患者的人口统计学特征。他们之间的groups.Results差异显着的原因包括不合格（50%），符合条件，但下降（47%），符合条件，但医生拒绝提供参与（2%），符合条件，但研究暂停（1%）。不合格的最常见原因是不符合方案特定的癌症分期、存在合并症以及不符合入选资格评分。符合条件的患者拒绝参与的最常见的原因是，他们没有愿望参加research.Conclusions该工具提供了有价值的信息，筛选和参加美国国家癌症研究所主办的试验，以及有关的障碍，在试验中招募的个人的特点。这些数据还为患者、提供者和机构层面的方案制定和干预提供了信息。
Background Clinical trial patient accrual continues to be challenging despite the identification of multiple physician, patient, and system barriers. Expanded collection of demographic data, including socioeconomic status (employment, income, education) and comorbidities, can enhance our understanding of the identified barriers, inform the development of interventions to overcome these barriers, and recognize their impact on treatment outcomes. A clinical trials screening tool was developed to collect expanded demographic data and barriers to trial enrollment; it has been implemented in the National Cancer Institute Clinical Oncology Research Program. The purpose of this article is to describe the development and implementation of the tool and to share information obtained during the first 43 months of its use.Methods There were 19,373 entries collected; 74% of those screened enrolled in a clinical trial. Demographic characteristics were compared between those screened and those enrolled. They varied significantly between the groups.Results Reasons for nonenrollment included ineligibility (50%), eligible but declined (47%), eligible but physician declined to offer participation (2%), and eligible but the study was suspended (1%). The most common reasons for ineligibility were failure to meet the protocol-specific stage of cancer, the presence of comorbidities, and the symptom-eligibility score was not met. The most common reason for eligible patients declining participation was that they had no desire to participate in research.Conclusions The tool provides valuable information about the characteristics of individuals who are screened and enrolled in National Cancer Institute-sponsored trials, as well as about barriers to enrollment in trials. The data also inform protocol development and interventions at the patient, provider, and institutional level.