A seamless Phase I/II platform design with a time-to-event efficacy endpoint for potential COVID-19 therapies

URN to cite this document:: urn:nbn:de:bvb:355-epub-777674
DOI to cite this document:: 10.5283/epub.77767

Jaki, Thomas

; Barnett, Helen ; Titman, Andrew ; Mozgunov, Pavel

License: Creative Commons Attribution 4.0
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Date of publication of this fulltext: 22 Sep 2025 06:25

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Abstract

In the search for effective treatments for COVID-19, the initial emphasis has been on re-purposed treatments. To maximize the chances of finding successful treatments, novel treatments that have been developed for this disease in particular, are needed. In this article, we describe and evaluate the statistical design of the AGILE platform, an adaptive randomized seamless Phase I/II trial platform ...