Embedding a COVID-19 Group Sequential Clinical Trial Within an Ongoing Trial: Lessons From an Unusual Experience

被引：8

作者：

Dequin, Pierre-Francois ^{[1
,2
]}

Le Gouge, Amelie ^{[3
]}

Tavernier, Elsa ^{[3
]}

Giraudeau, Bruno ^{[3
,4
]}

Zohar, Sarah ^{[5
]}

机构：

[1] CHRU Tours, Serv Med Intens Reanimat, Tours, France

[2] Univ Tours, Ctr Etud Pathol Resp, INSERM U1100, Tours, France

[3] CHRU Tours, INSERM CIC1415, Tours, France

[4] Univ Tours, Univ Nantes, SPHERE U1246, INSERM, Tours, France

[5] Univ Paris, Sorbonne Univ, Ctr Rech Cordeliers, INSERM, Paris, France

来源：

STATISTICS IN BIOPHARMACEUTICAL RESEARCH | 2020年 / 12卷 / 04期

关键词：

Adaptive design; Group-sequential designs; SARS-CoV-2; virus;

D O I：

10.1080/19466315.2020.1800509

中图分类号：

Q [生物科学];

学科分类号：

090105 [作物生产系统与生态工程];

摘要：

The Cape-Covid trial is an embedded clinical trial within the ongoing Cape-Cod trial. The Covid-19 pandemic appeared while we were conducting a randomized trial assessing the effectiveness of corticosteroids in severe community-acquired pneumonia. We took advantage of this ongoing trial to embed a sub-trial assessing hydrocortisone in SARS-CoV-2 infected patients. In this article, we wish to share our experience when we needed to make fast and robust methodological decisions during the Covid-19 pandemic in a two weeks period of time.for this article are available online.

引用

页码：478 / 482

页数：5

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