Futility analyses for the MCP-Mod methodology based on longitudinal models
Abstract
This article discusses futility analyses for the MCP-Mod methodology. Formulas are derived for calculating predictive and conditional power for MCP-Mod, which also cover the case when longitudinal models are used allowing to utilize incomplete data from patients at interim. A simulation study is conducted to evaluate the repeated sampling properties of the proposed decision rules and to assess the benefit of using a longitudinal versus a completer only model for decision making at interim. The results suggest that the proposed methods perform adequately and a longitudinal analysis outperforms a completer only analysis, particularly when the recruitment speed is higher and the correlation over time is larger. The proposed methodology is illustrated using real data from a dose-finding study for severe uncontrolled asthma.
Cite
@article{arxiv.2406.19965,
title = {Futility analyses for the MCP-Mod methodology based on longitudinal models},
author = {Björn Bornkamp and Jie Zhou and Dong Xi and Weihua Cao},
journal= {arXiv preprint arXiv:2406.19965},
year = {2024}
}