MAP-curvature: a model-free approach for analysis of dose-finding trials

Author:

Han LinxiORCID,Deng Qiqi,He ZhangyiORCID,Yu FengORCID

Abstract

AbstractMCP-Mod (Multiple Comparison Procedure-Modelling) is an efficient statistical method for the analysis of Phase II dose-finding trials, although it requires specialised expertise to pre-specify plausible candidate models along with model parameters. This can be problematic given limited knowledge of the agent/compound being studied. Misspecification of candidate models and model parameters can severely degrade its performance. To circumvent this challenge, in this work, we introduce MAP-curvature, a Bayesian model-free approach for the detection of the dose-response signal in Phase II dose-finding trials. MAP-curvature is built upon a Bayesian hierarchical method incorporating information about the total curvature of the dose-response curve. Through extensive simulations, we show that MAP-curvature has comparable performance to MCP-Mod if the true underlying dose-response model is included in the candidate model set of MCP-Mod. Otherwise, MAP-curvature can achieve performance superior to that of MCP-Mod, especially when the true dose-response model drastically deviates from candidate models in MCP-Mod.

Publisher

Cold Spring Harbor Laboratory

Reference8 articles.

1. Combining Multiple Comparisons and Modeling Techniques in Dose-Response Studies

2. Burden, R. L. , Faires, J. D. , & Burden, A. M. (2015). Numerical Analysis. Boston: Cengage Learning.

3. Statistical considerations on implementing the MCP-Mod method for binary endpoints in clinical trials;Contemporary Clinical Trials Communications,2020

4. Bayesian MCPMod;Phar-maceutical Statistics,2022

5. Nocedal, J. , & Wright, S. J. (1999). Numerical Optimization. New York: Springer.

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