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Equivalence tests under the Cox-Aalen model and the partly Aalen model

JOURNAL OF BIOPHARMACEUTICAL STATISTICS(2022)

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Abstract
For the equivalence trial with survivor outcomes from two treatment groups, the most popular testing procedure is the test proposed by under the proportional hazards (PH) model. In this article, when the treatment effect is time invariant, we demonstrate that the result under the PH model can be extended to the Cox-Aalen model. When the treatment effect is time-variant, we propose an equivalent test for the differences of two cumulative hazard functions under the partly Aalen model. Simulation studies show that the proposed tests perform well in finite samples. We illustrate the proposed tests using bladder cancer data and the primary biliary cirrhosis (PBC) data.
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Key words
Additive risk,relative risk,cumulative hazard,time-variant,type I error
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