应对大流行时管理临床研究的风险与益处。
Managing the risks and benefits of clinical research in response to a pandemic.
作者信息
Flume Patrick A, Berbari Elie F, Viera Laura, Hess Rachel, Higgins Janine, Armstrong Jennifer, Rice Linda, True Laura, Shaker Reza, Buse John B, Panettieri Reynold A
机构信息
Departments of Medicine and Pediatrics, Medical University of South Carolina, Charleston, SC, USA.
Department of Medicine, Mayo Clinic, Rochester, MN, USA.
出版信息
J Clin Transl Sci. 2021 Mar 30;5(1):e105. doi: 10.1017/cts.2021.14. eCollection 2021.
INTRODUCTION
The coronavirus disease 2019 (COVID-19) created major disruptions at academic centers and healthcare systems globally. Clinical and Translational Science Awards (CTSA) fund hubs supported by the National Center for Advancing Translational Sciences provideinfrastructure and leadership for clinical and translational research at manysuch institutions.
METHODS
We surveyed CTSA hubs and received responses from 94% of them regarding the impact of the pandemic and the processes employed for the protection of research personnel and participants with respect to the conduct of research, specifically for studies unrelated to COVID-19.
RESULTS
In this report, we describe the results of the survey findings in the context of the current understanding of disease transmission and mitigation techniques.
CONCLUSIONS
We reflect on common practices and provide recommendations regarding lessons learned that will be relevant to future pandemics, particularly with regards to staging the cessation and resumption of research activities with an aim to keep the workforce, research participants, and our communities safe in future pandemics.
引言
2019年冠状病毒病（COVID-19）在全球学术中心和医疗系统造成了重大干扰。由美国国立推进转化科学中心资助的临床与转化科学奖（CTSA）枢纽为许多此类机构的临床和转化研究提供基础设施和领导支持。
方法
我们对CTSA枢纽进行了调查，94%的枢纽回复了有关疫情影响以及在开展研究（特别是与COVID-19无关的研究）时用于保护研究人员和参与者的流程。
结果
在本报告中，我们结合当前对疾病传播和缓解技术的理解描述了调查结果。
结论
我们反思常见做法，并就吸取的经验教训提出建议，这些经验教训将与未来的大流行相关，特别是在安排研究活动的停止和恢复方面，目的是在未来大流行中保障工作人员、研究参与者和我们社区的安全。
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