ACTIV试验：在突发大流行背景下试验设计中吸取的经验教训。
ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic.
作者信息
Keshtkar-Jahromi Maryam, Anstrom Kevin J, Barkauskas Christina, Brown Samuel M, Daar Eric S, Fischer William, Gibbs Kevin W, Higgs Elizabeth S, Hughes Michael D, Jagannathan Prasanna, LaVange Lisa, Lindsell Christopher J, Nayak Seema U, Paredes Roger, Parmar Mahesh, Peltan Ithan D, Proschan Michael, Shotwell Matthew S, Vock David M, Yokum Tammy, Adam Stacey J
机构信息
Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
出版信息
J Clin Transl Sci. 2024 Oct 15;8(1):e151. doi: 10.1017/cts.2024.1. eCollection 2024.
Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develop and launch master protocols based on therapeutic targets and patient populations. The suite of clinical trials was designed to collectively inform therapeutic care for COVID-19 outpatient, inpatient, and intensive care populations globally. In this report, we highlight challenges, strategies, and solutions around clinical protocol development and regulatory approval to document our experience and propose plans for future similar healthcare emergencies.
加速COVID-19治疗干预和疫苗（ACTIV）项目由美国政府于2020年启动，旨在快速研发和测试针对COVID-19的疫苗及治疗方法。ACTIV治疗临床工作组挑选了ACTIV试验团队和临床网络，以便基于治疗靶点和患者群体迅速开展并推出主方案。这一系列临床试验旨在为全球范围内COVID-19门诊、住院和重症监护患者群体的治疗护理提供全面信息。在本报告中，我们重点介绍了临床方案制定和监管审批方面的挑战、策略及解决方案，以记录我们的经验并为未来类似的医疗紧急情况提出计划。
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