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临床试验参与的障碍:农村与城市参与者的比较研究

Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants.

作者信息

Mudaranthakam Dinesh Pal, Gajewski Byron, Krebill Hope, Coulter James, Springer Michelle, Calhoun Elizabeth, Hughes Dorothy, Mayo Matthew, Doolittle Gary

机构信息

University of Kansas Medical Center, Kansas City, KS, United States.

出版信息

JMIR Cancer. 2022 Apr 21;8(2):e33240. doi: 10.2196/33240.

Abstract

BACKGROUND

The National Clinical Trials Network program conducts phase 2 or phase 3 treatment trials across all National Cancer Institute's designated cancer centers. Participant accrual across these clinical trials is a critical factor in deciding their success. Cancer centers that cater to rural populations, such as The University of Kansas Cancer Center, have an additional responsibility to ensure rural residents have access and are well represented across these studies.

OBJECTIVE

There are scant data available regarding the factors that act as barriers to the accrual of rural residents in these clinical trials. This study aims to use electronic screening logs that were used to gather patient data at several participating sites in The Kansas University of Cancer Center's Catchment area.

METHODS

Screening log data were used to assess what clinical trial participation barriers are faced by these patients. Additionally, the differences in clinical trial participation barriers were compared between rural and urban participating sites.

RESULTS

Analysis revealed that the hospital location rural urban category, defined as whether the hospital was in an urban or rural setting, had a medium effect on enrolment of patients in breast cancer and lung cancer trials (Cohen d=0.7). Additionally, the hospital location category had a medium effect on the proportion of recurrent lung cancer cases at the time of screening (d=0.6).

CONCLUSIONS

In consideration of the financially hostile nature of cancer treatment as well as geographical and transportation barriers, clinical trials extended to rural communities are uniquely positioned to alleviate the burden of nonmedical costs in trial participation. However, these options can be far less feasible for patients in rural settings. Since the number of patients with cancer who are eligible for a clinical trial is already limited by the stringent eligibility criteria required of such a complex disease, improving accessibility for rural patients should be a greater focus in health policy.

摘要

背景

国家临床试验网络计划在所有美国国立癌症研究所指定的癌症中心开展2期或3期治疗试验。这些临床试验的受试者招募情况是决定其成败的关键因素。像堪萨斯大学癌症中心这样服务农村人口的癌症中心,还有额外的责任确保农村居民能够参与这些研究并在其中得到充分代表。

目的

关于阻碍农村居民参与这些临床试验的因素,可用数据很少。本研究旨在使用堪萨斯大学癌症中心服务区域内多个参与站点用于收集患者数据的电子筛查日志。

方法

筛查日志数据用于评估这些患者面临哪些临床试验参与障碍。此外,还比较了农村和城市参与站点在临床试验参与障碍方面的差异。

结果

分析显示,医院位置的农村/城市类别,即医院是位于城市还是农村地区,对乳腺癌和肺癌试验患者的入组有中等影响(科恩d值 = 0.7)。此外,医院位置类别对筛查时复发性肺癌病例的比例有中等影响(d值 = 0.6)。

结论

考虑到癌症治疗费用高昂以及地理和交通障碍,扩展到农村社区的临床试验在减轻试验参与中的非医疗成本负担方面具有独特优势。然而,对于农村地区的患者来说,这些选择可能可行性要低得多。由于符合临床试验条件的癌症患者数量已经受到这种复杂疾病严格入选标准的限制,提高农村患者的可及性应成为卫生政策中更重要的关注点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd7c/9073606/68e905eb53bd/cancer_v8i2e33240_fig1.jpg

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