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. 2020 Aug 19;12(4):478-482.
doi: 10.1080/19466315.2020.1800509.

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

Pierre-François Dequin  1 , Amélie Le Gouge  2 , Elsa Tavernier  2 , Bruno Giraudeau  2   3 , Sarah Zohar  4
Affiliations

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

Pierre-François Dequin et al. Stat Biopharm Res. .

Abstract

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.

Keywords: SARS-CoV-2 virus; group-sequential designs.

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Figures

Figure 1:
Figure 1:
Lan DeMets alpha-spending test stopping boundaries for the Cape-Covid trial
See this image and copyright information in PMC

References

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