Group sequential designs for clinical trials when the maximum sample size is uncertain

URN to cite this document:: urn:nbn:de:bvb:355-epub-777697
DOI to cite this document:: 10.5283/epub.77769

Yarahmadi, Amin ; Dodd, Lori E. ; Jaki, Thomas

; Horby, Peter ; Stallard, Nigel

License: Creative Commons Attribution 4.0
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Date of publication of this fulltext: 22 Sep 2025 06:51

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Abstract

Motivated by the experience of COVID-19 trials, we consider clinical trials in the setting of an emerging disease in which the uncertainty of natural disease course and potential treatment effects makes advance specification of a sample size challenging. One approach to such a challenge is to use a group sequential design to allow the trial to stop on the basis of interim analysis results as soon ...