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Article Dans Une Revue Statistics in Biopharmaceutical Research Année : 2020

Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience

Résumé

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 manuscript, 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.

Dates et versions

hal-03122980 , version 1 (27-01-2021)

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Citer

Pierre-François Dequin, Amélie Le Gouge, Elsa Tavernier, Bruno Giraudeau, Sarah Zohar. Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience. Statistics in Biopharmaceutical Research, 2020, 12 (4), pp.478-482. ⟨10.1080/19466315.2020.1800509⟩. ⟨hal-03122980⟩
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