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Non-constant hazard ratios in randomized controlled trials with composite endpoints

Author
Cortes, J.; Gomez, M.; Kim, K.; Gómez Melis, Guadalupe
Type of activity
Journal article
Journal
ArXiv
Date of publication
2019-07-25
Volume
1907
Number
10976
First page
1
Last page
17
Project funding
Statistical methods for clinical trials, complex censoring schemes and integrative omics data analysis
Repository
http://hdl.handle.net/2117/177525 Open in new window
https://arxiv.org/abs/1907.10976 Open in new window
Abstract
The hazard ratio is routinely used as a summary measure to assess the treatment effect in clinical trials with time-to-event endpoints. It is frequently assumed as constant over time although this assumption often does not hold. When the hazard ratio deviates considerably from being constant, the average of its plausible values is not a valid measure of the treatment effect, can be clinically misleading and common sample size formulas are not appropriate. In this paper, we study the hazard ratio...
Citation
Cortes, J. [et al.]. Non-constant hazard ratios in randomized controlled trials with composite endpoints. "ArXiv", 25 Juliol 2019, vol. 1907, núm. 10976, p. 1-17.
Keywords
Composite endpoint, Copula, Non-Proportional Hazard, Progression-Free Survival, Randomized Controlled Trial, Treatment Effect
Group of research
GRBIO - Biostatistics and Bioinformatics Research Group

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