Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience.
Stat Biopharm Res
; 12(4): 478-482, 2020 Aug 19.
Article
in English
| MEDLINE | ID: covidwho-670197
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Language:
English
Journal:
Stat Biopharm Res
Year:
2020
Document Type:
Article
Affiliation country:
19466315.2020.1800509
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