Abstract
We discuss the design and analysis of trials of drugs and biologics designed to combat sepsis. We consider the variety of trials that have been conducted, and comment on the problems that have occurred in their conduct. These include variation in populations, therapies, controls, and endpoints. Optimistic estimates of effect sizes have led to studies which have been underpowered. Analyses using the proportional hazards model may be underpowered if the data do not satisfy the assumption of proportionality.
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© 1997 Springer-Verlag New York, Inc.
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Lachenbruch, P.A., Tiwari, J. (1997). Proposed Strategies for Designing and Analysing Sepsis Trials. In: Lin, D.Y., Fleming, T.R. (eds) Proceedings of the First Seattle Symposium in Biostatistics. Lecture Notes in Statistics, vol 123. Springer, New York, NY. https://doi.org/10.1007/978-1-4684-6316-3_13
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DOI: https://doi.org/10.1007/978-1-4684-6316-3_13
Publisher Name: Springer, New York, NY
Print ISBN: 978-0-387-94992-5
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