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量化 COVID-19 大流行对癌症中心临床试验运作的影响。

Quantifying the impact of the COVID-19 pandemic on cancer center clinical trial operations.

机构信息

University of Florida Health Cancer Center, Gainesville, FL, USA.

University of Kansas Cancer Center, Kansas City, KS, USA.

出版信息

JNCI Cancer Spectr. 2023 Jul 3;7(4). doi: 10.1093/jncics/pkad048.

DOI:10.1093/jncics/pkad048
PMID:37467065
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10463546/
Abstract

BACKGROUND

Oncology clinical trials are complex, and the COVID-19 pandemic caused major disruptions in 2020.

METHODS

Using its networking and sharing of best practices, the Association of American Cancer Institutes, comprising 105 cancer centers, solicited a longitudinal series of voluntary surveys from members to assess how clinical trial office operations were affected. The surveys showed that centers were able to keep oncology trials available to patients while maintaining safety. Data were collected regarding interventional clinical trial accruals for the calendar years 2019, 2020, and 2021.

RESULTS

Data demonstrated a sizeable decrease in interventional treatment trial accruals in both 2020 and 2021 compared with prepandemic figures in 2019. No cancer center reported an increase in interventional treatment trial accruals in 2020 compared with 2019, with most centers reporting a moderate decrease. In mid-2022, 15% of respondents reported an increasing trend, 31% reported no significant change, and 54% continued to report a decrease.

CONCLUSIONS

The pandemic necessitated rapid adoption of trial operations, with the emergence of several best practices, including remote monitoring, remote consenting, electronic research charts, and work-from-home strategies for staff. The national infrastructure to conduct trials was significantly affected by the pandemic, with noteworthy resiliency, evidenced by improvements in efficiencies and patient-centered care delivery but with residual capacity challenges that will be evident for the foreseeable future.

摘要

背景

肿瘤学临床试验较为复杂,2020 年的 COVID-19 大流行造成了严重干扰。

方法

美国癌症协会(由 105 个癌症中心组成)利用其网络和最佳实践共享,向成员征集了一系列纵向自愿调查,以评估临床试验办公室的运作情况受到了怎样的影响。调查显示,各中心在保持安全的同时,能够为患者提供肿瘤学试验。收集了 2019、2020 和 2021 年日历年度干预性临床试验入组的数据。

结果

数据表明,与 2019 年大流行前的数据相比,2020 年和 2021 年干预性治疗试验的入组数量大幅减少。与 2019 年相比,没有癌症中心报告 2020 年干预性治疗试验的入组数量有所增加,大多数中心报告入组数量中等减少。2022 年年中,15%的受访者报告入组呈上升趋势,31%报告无显著变化,54%继续报告入组减少。

结论

疫情需要迅速采用试验操作,出现了一些最佳实践,包括远程监测、远程知情同意、电子研究图表以及工作人员居家办公策略。全国进行试验的基础设施受到疫情的严重影响,但具有明显的弹性,这体现在效率和以患者为中心的护理提供方面的改进,但在可预见的未来仍存在剩余能力方面的挑战。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/2b8afc1ef662/pkad048f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/5d910461ff36/pkad048f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/88872c1d52c8/pkad048f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/472e780fdf1d/pkad048f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/1b4f74b4d0d7/pkad048f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/2b8afc1ef662/pkad048f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/5d910461ff36/pkad048f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/88872c1d52c8/pkad048f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/472e780fdf1d/pkad048f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/1b4f74b4d0d7/pkad048f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a330/10463546/2b8afc1ef662/pkad048f5.jpg

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