ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic.

IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Journal of Clinical and Translational Science Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI:10.1017/cts.2024.1

Maryam Keshtkar-Jahromi, Kevin J Anstrom, Christina Barkauskas, Samuel M Brown, Eric S Daar, William Fischer, Kevin W Gibbs, Elizabeth S Higgs, Michael D Hughes, Prasanna Jagannathan, Lisa LaVange, Christopher J Lindsell, Seema U Nayak, Roger Paredes, Mahesh Parmar, Ithan D Peltan, Michael Proschan, Matthew S Shotwell, David M Vock, Tammy Yokum, Stacey J Adam

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Abstract

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.

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ACTIV 试验：在突发大流行病背景下设计试验的经验教训。

加速 COVID-19 治疗干预和疫苗 (ACTIV) 由美国政府发起，旨在 2020 年快速开发和测试针对 COVID-19 的疫苗和疗法。ACTIV 疗法-临床工作组选择了 ACTIV 试验团队和临床网络，以根据治疗目标和患者群体快速开发和启动主方案。这套临床试验旨在为全球 COVID-19 门诊、住院和重症监护人群的治疗护理提供集体信息。在本报告中，我们重点介绍了临床方案开发和监管审批方面的挑战、策略和解决方案，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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