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A new approach for sizing trials with composite binary endpoints using anticipated marginal values and accounting for the correlation between components

Author
Bofill, M.; Gómez Melis, Guadalupe
Type of activity
Journal article
Journal
Statistics in medicine
Date of publication
2019-05-20
Volume
38
Number
11
First page
1935
Last page
1956
DOI
10.1002/sim.8092
Project funding
Barcelona Graduate School of Mathematics
Grup de recerca en bioestadística i bioinformàtica
New methods and techniques for the design, construction, assessment and strengthening of concrete structures
Statistical methods for clinical trials, complex censoring schemes and integrative omics data analysis
Repository
http://hdl.handle.net/2117/171418 Open in new window
URL
https://onlinelibrary.wiley.com/doi/full/10.1002/sim.8092 Open in new window
Abstract
Composite binary endpoints are increasingly used as primary endpoints in clinical trials. When designing a trial, it is crucial to determine the appropriate sample size for testing the statistical differences between treatment groups for the primary endpoint. As shown in this work, when using a composite binary endpoint to size a trial, one needs to specify the event rates and the effect sizes of the composite components as well as the correlation between them. In practice, the marginal paramete...
Citation
Bofill, M.; Gómez Melis, G. A new approach for sizing trials with composite binary endpoints using anticipated marginal values and accounting for the correlation between components. "Statistics in medicine", 20 Maig 2019, vol. 38, núm. 11, p. 1935-1956.
Keywords
composite binary endpoints, correlated endpoints, sample size
Group of research
GRBIO - Biostatistics and Bioinformatics Research Group

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