Decision tool and Sample Size Calculator for composite endpoints
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This article considers the combination of two binary or two time-to-event endpoints to form the primary composite endpoint for leading a trial. • It discusses the relative efficiency of choosing a composite endpoint over one of its components in terms of: the frequencies of observing each component; the relative treatment effect of the tested therapy; and the association between both components. • We highlight the very important role of the association between components in choosing the most efficient endpoint to use as primary. • For better grounded future trials, we recommend trialists to always reporting the association between components of the composite endpoint • Common fallacies to note when using composite endpoints: i) composite endpoints always imply higher power; ii) treatment effect on the composite endpoint is similar to the average effects of its components; and iii) the probability of observing the primary endpoint increases significantly.
CitationBofill, M.; Cortes, J.; Gómez Melis, G. Decision tool and Sample Size Calculator for composite endpoints. "ArXiv", 10 Gener 2020, vol. 03396, p. 1-7.
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