An Alternative to Traditional Sample Size Determination for Small Patient Populations

URN to cite this document:: urn:nbn:de:bvb:355-epub-778398
DOI to cite this document:: 10.5283/epub.77839

Jackson, Holly ; Jaki, Thomas

License: Creative Commons Attribution 4.0
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Date of publication of this fulltext: 25 Sep 2025 12:15

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Abstract

The majority of phase III clinical trials use a 2-arm randomized controlled trial with 50% allocation between the control treatment and experimental treatment. The sample size calculated for these clinical trials normally guarantee a power of at least 80% for a certain Type I error, usually 5%. However, these sample size calculations, do not typically take into account the total patient ...