51. Futility analyses for the MCP-Mod methodology based on longitudinal models
- Author
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Bornkamp, Björn, Zhou, Jie, Xi, Dong, and Cao, Weihua
- Subjects
Statistics - Methodology ,Statistics - Applications - 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.
- Published
- 2024