Login / Signup

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

Pierre-François DequinAmélie Le GougeElsa TavernierBruno GiraudeauSarah Zohar
Published in: Statistics in biopharmaceutical research (2020)
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.
Keyphrases