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大流行时代的心血管临床试验。

Cardiovascular clinical trials in the era of a pandemic.

机构信息

Department of Cardiology Bern University Hospital Bern Switzerland.

出版信息

J Am Heart Assoc. 2020 Oct 20;9(20):e018288. doi: 10.1161/JAHA.120.018288. Epub 2020 Sep 30.

Abstract

COVID-19 has reached pandemic levels in March 2020 and impacted public health with unpredictable consequences. The conduct of clinical research in areas unrelated to COVID-19 has been disrupted and will be further affected. Researchers, trial participants and study personnel have to overcome challenges to sustain proper and safe conduct of clinical trials (i.e. logistical challenges, lower enrollment than expected, difficulties in follow-up and outcome assessment/adjudication, incomplete data collection, research funding prolongation).

摘要

2020 年 3 月,COVID-19 已达到大流行水平,对公共卫生产生了不可预测的影响。与 COVID-19 无关的临床研究工作受到干扰,且将会受到进一步影响。研究人员、试验参与者和研究人员必须克服各种挑战,以维持临床试验的适当和安全进行(即后勤方面的挑战、入组人数低于预期、随访和结局评估/裁定困难、数据收集不完整、研究资金延长)。

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