Adaptive Isotonic Estimation of the Minimum Effective and Peak Doses in the Presence of Covariates |
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Authors: | Xiao Changfu Ivanova Anastasia |
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Institution: | Department of Biostatistics, University of North Carolina, Chapel Hill, NC 27599-7420, USA. |
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Abstract: | We consider a problem of estimating the minimum effective and peak doses in the presence of covariates. We propose a sequential strategy for subject assignment that includes an adaptive randomization component to balance the allocation to placebo and active doses with respect to covariates. We conclude that either adjusting for covariates in the model or balancing allocation with respect to covariates is required to avoid bias in the target dose estimation. We also compute optimal allocation to estimate the minimum effective and peak doses in discrete dose space using isotonic regression. |
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Keywords: | Dose-ranging Minimum effective dose Peak dose Phase II trials Up-and-down designs |
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