COVID-19 时代的临床试验实施：JACC 科学专家小组。
Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.
机构信息
Inova Heart and Vascular Institute, Falls Church, Virginia. Electronic address: https://twitter.com/mpsotka.
Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.
出版信息
J Am Coll Cardiol. 2020 Nov 17;76(20):2368-2378. doi: 10.1016/j.jacc.2020.09.544.
Abstract
The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment. The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory and the Academic Research Consortium, composed of academic investigators from the United States and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health, and industry members. A series of meetings were convened to address the challenges caused by the COVID-19 pandemic, review options for maintaining or altering best practices, and establish key recommendations for the conduct and analysis of clinical trials for cardiovascular disease and heart failure. This paper summarizes the discussions and expert consensus recommendations.
摘要
新型冠状病毒病-2019（COVID-19）大流行极大地改变了临床护理和研究，包括临床试验的开展，临床研究生态系统将需要适应这一变化的环境。心力衰竭学术研究联盟是心力衰竭协作研究中心与学术研究联盟之间的合作关系，由来自美国和欧洲的学术研究人员、患者、美国食品和药物管理局、美国国立卫生研究院以及行业成员组成。召开了一系列会议，以解决 COVID-19 大流行带来的挑战，审查维持或改变最佳实践的方案，并为心血管疾病和心力衰竭临床试验的开展和分析制定关键建议。本文总结了讨论和专家共识建议。
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