Titlebook: Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Anal; Selected Papers from Jianchang Lin,Bu

Immortal

Optimal Biomarker-Guided Design for Targeted Therapy with Imperfectly Measured Biomarkersing to the patient’s biomarker profile. The implementation of targeted therapy requires that the biomarkers are accurately measured, which may not always be feasible in practice. In this article, we propose two optimal biomarker-guided trial designs in which the biomarkers are subject to measurement

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Statistical Considerations for Evaluating Prognostic Biomarkers: Choosing Optimal Thresholdpractice, a threshold or cutpoint is required for dichotomizing continuous markers to distinguish patients with certain conditions or responses from those who are without. Two popular ROC based methods to establish “optimal” threshold are based on Youdan index J and closest top-left criterion. We ha

IST

Accuracy of Meta-Analysis Using Different Levels of Diagnostic Accuracy Measureszes these diagnostic accuracy measures from different studies to obtain an overall summary ROC curve. Increasingly, meta analysis also uses individual patient level data. However, the pro and con of such an approach are not entirely clear. In this paper, we performed a simulation study to evaluate t

明智的人

Campaign

Bayesian Integration of In Vitro Biomarker to Analysis of In Vivo Safety Assessmentrisks of a drug in human, it has been proposed to better integrate in vitro and in vivo models for preclinical QT prolongation assessment (Hanson et al., J Pharmacol Toxicol Methods 54:116–129, 2006). By evaluation of the Health and Environmental Sciences Institute of the International Life Sciences

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browbeat

非秘密

Personalized Effective Dose Selection in Dose Ranging Studiesies. Our research is motivated by a real randomized, double-blind, placebo-controlled phase II dose-ranging study with genetic markers. One goal of the analysis is to identify subgroups with enhanced benefit/risk profiles with approriate doses and inform the study design of future phase III trials.

ETHER

Evaluation of Consistency Requirements in Multi-Regional Clinical Trials with Different Endpointsefully designed MRCT could be used in supporting the new drug’s approval in different regions simultaneously. The primary objective of an MRCT is to investigate the drug’s overall efficacy across regions while also assessing the drug’s performance in some specific regions. In order to claim the stud

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