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大规模、快节奏开展 COVID-19 临床试验:RECOVERY 试验经验。

Establishing COVID-19 trials at scale and pace: Experience from the RECOVERY trial.

机构信息

Nuffield Department of Population Health, University of Oxford, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Oxford, UK.

Pandemic Sciences Institute, University of Oxford, Oxford, UK.

出版信息

Adv Biol Regul. 2022 Dec;86:100901. doi: 10.1016/j.jbior.2022.100901. Epub 2022 Jul 19.

Abstract

The Randomised Evaluation of COVID-19 Therapy (RECOVERY) Trial was set up in March 2020 to evaluate treatments for people hospitalised with COVID-19. To maximise recruitment it was designed to fit into routine clinical care throughout the UK, and as a result it has enrolled more patients than any other COVID-19 treatment trial. RECOVERY has shown four drugs to be life-saving - dexamethasone, tocilizumab, baricitinib and casirivimab-imdevimab - and a further six have been shown to be of little or no benefit. In each case, results from RECOVERY were clear enough to rapidly influence global practice. Some of the reasons for this success relate to its particular setting in the UK during the SARS-CoV-2 pandemic, but many are generalisable to other contexts. In particular, its focus on recruiting large numbers of patients to identify or rule out moderate but worthwhile benefits of treatment, and the design decisions that followed from this. Similar large streamlined trials could produce similarly clear answers about the treatment of many other common diseases.

摘要

随机对照 COVID-19 治疗试验(RECOVERY)于 2020 年 3 月成立,旨在评估治疗 COVID-19 住院患者的方法。为了最大程度地招募患者,该试验设计旨在适应英国各地的常规临床护理,因此它招募的患者比任何其他 COVID-19 治疗试验都多。RECOVERY 试验已证实四种药物具有救生作用 - 地塞米松、托珠单抗、巴瑞替尼和卡瑞利珠单抗- 以及另外六种药物几乎或没有益处。在每种情况下,RECOVERY 的结果都足以迅速影响全球实践。其成功的部分原因与其在 SARS-CoV-2 大流行期间在英国的特定环境有关,但许多原因是普遍适用的。特别是,RECOVERY 专注于招募大量患者,以确定或排除治疗的中等但有价值的益处,以及由此产生的设计决策。类似的大型简化试验可能会对许多其他常见疾病的治疗产生类似明确的答案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f30/9293394/c1685116b2ea/gr1_lrg.jpg

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