Abstract:
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Assessments of treatment effects on specific individuals in clinical trials are essential as a treatment may work well in some patients but it could be harmful to others with apparently the same disease. Identifying subset of responsive patients is a challenge in trials where a treatment efficacy is often measured by various continuous and count longitudinally-collected outcomes. Therefore, existing procedures often identify the subset based only on a single outcome. We propose a latent class clustering approach to identify the responsive patients based on a multiple longitudinal outcome mixture model. Our novel model assumes that, conditioning on a cluster label, a single outcome is modelled with the generalized linear mixed effect model, a rich class of models for longitudinal analysis, and the maximum likelihood estimates of our high dimensional model is attained by utilizing the Monte Carlo expectation-maximization algorithm. We will demonstrate our novel procedure based on a MS clinical trial dataset.
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