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Erschienen in:

2016 | OriginalPaper | Buchkapitel

Statistical Considerations in Infectious Disease Randomized Controlled Trials

verfasst von : Matthew J. Hayat

Erschienen in: Mathematical and Statistical Modeling for Emerging and Re-emerging Infectious Diseases

Verlag: Springer International Publishing

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Abstract

Randomized controlled trials (RCT) provide the highest standard of evidence available for assessing treatment efficacy. Causal inferences are enabled and effects may be directly attributed to a treatment. The nature of infectious disease presents challenges to the design, conduct, and analysis of a trial for a new drug or therapy. Many of these challenges are statistical in nature and can be addressed with modern methods for planning and analyzing RCT data. In this chapter, some of these challenges are described and reviewed. Modern statistical modeling methods for analysis of correlated data are covered. Some challenges with sample size determination are outlined and updated methods for data monitoring, interim, and subgroup analyses detailed. Also, discernment is made between multisite and cluster randomized trials. Recommendations for best practices are included.

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Vorheriges Kapitel Methods to Determine the End of an Infectious Disease Epidemic: A Short Review

Nächstes Kapitel Epidemic Models With and Without Mortality: When Does It Matter?

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Titel: Statistical Considerations in Infectious Disease Randomized Controlled Trials
verfasst von: Matthew J. Hayat
Verlag: Springer International Publishing
Buch: Mathematical and Statistical Modeling for Emerging and Re-emerging Infectious Diseases
Print ISBN: 978-3-319-40411-0

Electronic ISBN: 978-3-319-40413-4

Copyright-Jahr: 2016
DOI: https://doi.org/10.1007/978-3-319-40413-4_18

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