Futility analyses for the MCP-Mod methodology based on longitudinal models
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arXiv
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| Hauptverfasser: | , , , |
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| Format: | Preprint |
| Veröffentlicht: |
2024
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| _version_ | 1866917708221644800 |
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| author | Bornkamp, Björn Zhou, Jie Xi, Dong Cao, Weihua |
| author_facet | Bornkamp, Björn Zhou, Jie Xi, Dong Cao, Weihua |
| contents | 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. |
| format | Preprint |
| id |
arxiv_https___arxiv_org_abs_2406_19965 |
| institution | arXiv |
| publishDate | 2024 |
| record_format | arxiv |
| spellingShingle | Futility analyses for the MCP-Mod methodology based on longitudinal models Bornkamp, Björn Zhou, Jie Xi, Dong Cao, Weihua Methodology Applications 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. |
| title | Futility analyses for the MCP-Mod methodology based on longitudinal models |
| topic | Methodology Applications |
| url | https://arxiv.org/abs/2406.19965 |