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Finding translational biomarkers stands center stage of the future of personalized medicine in healthcare. We observed notable challenges in identifying robust biomarkers as some with great performance in one scenario often fail to perform well in new trials (e.g. different population, indications). With rapid development in the clinical trial world (e.g. assay, disease definition), new trials very likely differ from legacy ones in many perspectives and in development of biomarkers this heterogeneity should be considered. In response, we recommend considering building in the heterogeneity when evaluating biomarkers. In this paper, we present one evaluation strategy by using leave-one-study-out (LOSO) in place of conventional cross-validation (cv) methods to account for the potential heterogeneity across trials used for building and testing the biomarkers. To demonstrate the performance of K-fold vs LOSO cv in estimating the effect size of biomarkers, we leveraged data from clinical trials and simulation studies. In our assessment, LOSO cv provided a more objective estimate of the future performance. This conclusion remained true across different evaluation metrics and different statistical methods.
Just-in-time adaptive interventions (JITAIs) are time-varying adaptive interventions that use frequent opportunities for the intervention to be adapted--weekly, daily, or even many times a day. The micro-randomized trial (MRT) has emerged for use in
Developing spatio-temporal crime prediction models, and to a lesser extent, developing measures of accuracy and operational efficiency for them, has been an active area of research for almost two decades. Despite calls for rigorous and independent ev
Is it possible for a large sequence of measurements or observations, which support a hypothesis, to counterintuitively decrease our confidence? Can unanimous support be too good to be true? The assumption of independence is often made in good faith,
Optimization algorithms and Monte Carlo sampling algorithms have provided the computational foundations for the rapid growth in applications of statistical machine learning in recent years. There is, however, limited theoretical understanding of the
Background: All states in the US have enacted at least some naloxone access laws (NALs) in an effort to reduce opioid overdose lethality. Previous evaluations found NALs increased naloxone dispensing but showed mixed results in terms of opioid overdo