New Developments in Statistical Modeling, Inference and Application by Zhezhen Jin Mengling Liu & Xiaolong Luo

Author:Zhezhen Jin, Mengling Liu & Xiaolong Luo
Language: eng
Format: epub
Publisher: Springer International Publishing, Cham

2.2 Modeling of Time Response and Dose Response

To specify the models, denote the primary endpoint of subject i at dose d and time t as Y i, d, t , d = 1, 2, 3, 4, t = 1, 2, where d = 1 is for placebo and d = 2, 3, 4 are for the low, middle, and high doses of the tested drug; t = 1 is for the time point of the interim measurement of the primary efficacy measure and t = 2 is for the primary time point at the end of treatment. Although the notation as well as the models to be defined are for the specific trial here considered, they can be extended to cases with more time points or doses. Observations at the primary time point were first predicted for patients that were still in the trial but had not progressed to the end of treatment. The predicted values along with the observed at the primary time point were then analyzed through a dose response model. To note, only patients with an interim or a final observation were included in the analysis.

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