2019年冠状病毒病对国家临床试验网络乳腺癌试验的影响
The Impact of COVID-19 on National Clinical Trials Network Breast Cancer Trials.
作者信息
Ndumele Amara, Park Ko Un
机构信息
College of Medicine, The Ohio State University, Columbus, OH USA.
Division of Surgical Oncology, Department of Surgery, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH USA.
出版信息
Curr Breast Cancer Rep. 2021;13(3):103-109. doi: 10.1007/s12609-021-00417-z. Epub 2021 May 12.
PURPOSE OF REVIEW
The COVID-19 pandemic has had a devastating impact on virtually all aspects of the healthcare system, including oncology clinical trials. The purpose of this review is to describe the impact of the pandemic on national breast cancer clinical trials.
RECENT FINDINGS
Of the 61 breast cancer-specific cooperative group breast cancer clinical trials open to accrual during the pandemic, 32% of them received supplementary tailored guidance regarding current and foreseeable challenges for clinical sites and investigators due to COVID-19. Many clinical trial sites reported decreases in enrollment and accrual, drastic disruptions to protocol, and challenges related to research infrastructure, staff burden, and assuring social distancing.
SUMMARY
The challenges early in pandemic led to many operational changes in clinical trials, including use of electronic consent for enrollment, telemedicine visits, and mail order pharmacy. The pandemic highlighted aspects of breast cancer clinical trial that could be modernized while maintaining research integrity.
综述目的
新冠疫情对医疗系统的几乎所有方面都产生了毁灭性影响，包括肿瘤学临床试验。本综述的目的是描述疫情对全国乳腺癌临床试验的影响。
最新发现
在疫情期间开放入组的61项乳腺癌特异性协作组乳腺癌临床试验中，32%的试验因新冠疫情获得了针对临床机构和研究者当前及可预见挑战的补充性定制指导。许多临床试验机构报告称入组和病例积累减少、方案严重中断，以及在研究基础设施、工作人员负担和确保社交距离方面存在挑战。
总结
疫情早期的挑战导致了临床试验中的许多操作变化，包括使用电子知情同意书进行入组、远程医疗问诊和邮购药房。疫情凸显了乳腺癌临床试验中在保持研究完整性的同时可以实现现代化的方面。
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