Flexible Phase I Clinical Trials: Allowing for Nonbinary Toxicity Response and Removal of Other Common Limitations [0.03%]
灵活的I期临床试验：允许非二元毒性反应并消除其他常见限制
Richard F Potthoff,Stephen L George
Richard F Potthoff
Phase I clinical trials are often subject to severe limitations. The most important one is that they typically allow only for binary response-toxic (1) or nontoxic (0)-rather than a range of responses from 0 to 1. They also may not allow a ...
Haiyan Su,Yongsong Qin,Hua Liang
Haiyan Su
In this article we propose an empirical likelihood-based confidence interval for receiver operating characteristic curves which are based on a continuous-scale test. The approach is easily understood, simply implemented, and computationally...
Detecting Genes and Gene-gene Interactions for Age-related Macular Degeneration with a Forest-based Approach [0.03%]
基于森林算法的年龄相关性黄斑变性的基因及基因互作检测研究
Minghui Wang,Meizhuo Zhang,Xiang Chen et al.
Minghui Wang et al.
Age-related macular degeneration (AMD) is a leading cause of vision loss in the elderly. Genetic mechanisms underlying AMD are complex. Understanding the etiology of AMD is important because of the significant health and social concerns. In...
Anastasia Ivanova,Nancy Flournoy
Anastasia Ivanova
We compare several decision rules for allocating subjects to dosages that are based on sequential isotonic estimates of a monotone dose-toxicity curve. We conclude that the decision rule in which the next assignment is to the dose having pr...
Simultaneous Evaluation of the Magnitude and Breadth of a Left and Right Censored Multivariate Response, with Application to HIV Vaccine Development [0.03%]
同时评估左、右截尾多元反应的大小和广度，及其在HIV疫苗开发中的应用
Yunda Huang,Peter B Gilbert,David C Montefiori et al.
Yunda Huang et al.
Both the magnitude and breadth of neutralization against multiple strains of virus are main endpoints for comparing antibody-based HIV-1 vaccine candidates in Phase I and II trials, and are key markers to be evaluated in vaccine efficacy tr...
Methods for Assessing Improvement in Specificity when a Biomarker is Combined with a Standard Screening Test [0.03%]
生物标志物与标准筛查试验联合使用时评估特异度改善的方法
Pamela A Shaw,Margaret S Pepe,Todd A Alonzo et al.
Pamela A Shaw et al.
Biomarkers that can be used in combination with established screening tests to reduce false positive rates are in considerable demand. In this article, we present methods for evaluating the diagnostic performance of combination tests that r...
Confidence Intervals of Interaction Index for Assessing Multiple Drug Interaction [0.03%]
用于评估多重药物相互作用的交互指数置信区间
J Jack Lee,Maiying Kong
J Jack Lee
Studies of interactions among biologically active agents have become increasingly important in many branches of biomedical research. We consider that the Loewe additivity model is one of the best general reference models for defining drug i...
Robust Non-inferiority Tests for Potency of a Test Drug Against a Reference Drug: (To appear in Statistics in Biopharmaceutical Research ) [0.03%]
一种药物与另一种对照药物相比功效的非劣性检验方法：(将出现在生物制药研究统计学中)
Michael P Fay,Farzad Noubary,Allan Saul
Michael P Fay
In comparing test formulations of a drug product to reference formulations it is necessary to check that the test formulation has as much biologic activity as the reference within some indifference zone. A modern method for testing this rel...
Julia N Soulakova,Allan R Sampson
Julia N Soulakova
To determine that a combination drug is effective, the FDA requires demonstration that the combination itself is effective and that each component makes a contribution to the claimed effect. In a study with at least one component known to b...