Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience.
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ABSTRACT:
SUBMITTER: Dequin PF
PROVIDER: S-EPMC8008347 | biostudies-literature | 2020 Aug
REPOSITORIES: biostudies-literature
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Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience.
Dequin Pierre-François PF Gouge Amélie Le AL Tavernier Elsa E Giraudeau Bruno B Zohar Sarah S
Statistics in biopharmaceutical research 20200819 4
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- ...[more]
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