Abstract
Analysis of sepsis research studies involving laboratory animal models is straightforward. In such models, all potential prognostic factors such as genetic predisposition, age, sex, infecting organism, inoculum of organisms, time between infection and treatment, environmental conditions, etc… can be specified and standardized between animals in each of the two treatment arms of an experiment. Differences in outcome can, therefore, be ascribed solely to the differences in applied therapy and the relevance of these differences precisely determined by statistics. This experimental purity is rarely achievable in clinical trials. In human trials, the heterogeneity of the patients enrolled in the trial becomes a prominent factor and the complexity, both in design and analysis, increases tremendously.
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Dellinger, R.P., Straube, R.C. (1992). Dilemmas in Sepsis Clinical Trials Design and Analysis. In: Lamy, M., Thijs, L.G. (eds) Mediators of Sepsis. Update in Intensive Care and Emergency Medicine, vol 16. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-84827-8_20
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DOI: https://doi.org/10.1007/978-3-642-84827-8_20
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