Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials

When a candidate predictive marker is available, but evidence on its predictive ability is not sufficiently reliable, all‐comers trials with marker stratification are frequently conducted. We propose a framework for planning and evaluating prospective testing strategies in confirmatory, phase III marker‐stratified clinical trials based on a natural assumption on heterogeneity of treatment effects across marker‐defined subpopulations, where weak rather than strong control is permitted for multiple population tests. For phase III marker‐stratified trials, it is expected that treatment efficacy is established in a particular patient population, possibly in a marker‐defined subpopulation, and that the marker accuracy is assessed when the marker is used to restrict the indication or labelling of the treatment to a marker‐based subpopulation, ie, assessment of the clinical validity of the marker. In this paper, we develop statistical testing strategies based on criteria that are explicitly designated to the marker assessment, including those examining treatment effects in marker‐negative patients. As existing and developed statistical testing strategies can assert treatment efficacy for either the overall patient population or the marker‐positive subpopulation, we also develop criteria for evaluating the operating characteristics of the statistical testing strategies based on the probabilities of asserting treatment efficacy across marker subpopulations. Numerical evaluations to compare the statistical testing strategies based on the developed criteria are provided.     

互联网时代的信息传播悖论

互联网上存在这样一个悖论——一方面是海量信息 ,另一方面却是垃圾信息 ,有用信息难以查找 ,文章分析了这一现象产生的原因及其对网络生态环境的危害 ,并初步提出了解决方法。     

当代西方关于全球性问题的哲理反思

当代人类面临种种全球性问题,科技社会效应的两重性空前突出。当代西方思想界出现了一场科技悲观论与科技乐观论的激烈论争。对这场极具哲理性的争论应给予全面分析并加以总结,这将有助于马克思主义的科技价值论和生态哲学观的深化和发展。     

小波分析在管理数据处理中的应用

提出了一种基于小波变换的管理数据处理方法，把公司管理上的数据看成一个非平稳的时间序列，利用小渡函数将该时间序列分解到不同的频率通道上，然后将分解后的信号当作近似的平稳时间序列，用一些传统的统计方法进行预测，同时对中国足球彩票若干期的销售量数据进行了处理和预测，并将结果与实际销量以及用传统的AR模型的预测值进行了比较。     

阿兰·奈斯论深层生态学的哲学基础

在阿兰·奈斯看来 ,深层生态学既是一种社会思潮 ,又是以这种思潮为指导的一场旨在改变现行实践模式的社会运动。作为一种社会思潮 ,它是一个由一系列基本原理构成的演绎性的逻辑体系。奈斯认为 ,深层生态学的理论内核是八大原理 ,而在其背后 ,还有更为基本的前提与终极规范 ,即各种生态智慧。而奈斯本人的生态智慧的终极规范是 (大 )自我实现     

非统计专业统计学教育刍议

针对非统计专业统计学教育目前存在的问题,阐述了提高对统计学重要性的认识是保证统计教学效果的前提;统计学教学环节的改革是提高教学效果的重要保证;统计教师的业务素质是提高统计教学效果的关键。     

Statistical Distributions of Daily Breathing Rates for Narrow Age Groups of Infants and Children

Children may be more susceptible to toxicity from some environmental chemicals than adults. This susceptibility may occur during narrow age periods (windows), which can last from days to years depending on the toxicant. Breathing rates specific to narrow age periods are useful to assess inhalation dose during suspected windows of susceptibility. Because existing breathing rates used in risk assessment are typically for broad age ranges or are based on data not representative of the population, we derived daily breathing rates for narrow age ranges of children designed to be more representative of the current U.S. children's population. These rates were derived using the metabolic conversion method of Layton (1993) and energy intake data adjusted to represent the U.S. population from a relatively recent dietary survey (CSFII 1994–1996, 1998). We calculated conversion factors more specific to children than those previously used. Both nonnormalized (L/day) and normalized (L/kg-day) breathing rates were derived and found comparable to rates derived using energy estimates that are accurate for the individuals sampled but not representative of the population. Estimates of breathing rate variability within a population can be used with stochastic techniques to characterize the range of risk in the population from inhalation exposures. For each age and age-gender group, we present the mean, standard error of the mean, percentiles (50th, 90th, and 95th), geometric mean, standard deviation, 95th percentile, and best-fit parametric models of the breathing rate distributions. The standard errors characterize uncertainty in the parameter estimate, while the percentiles describe the combined interindividual and intra-individual variability of the sampled population. These breathing rates can be used for risk assessment of subchronic and chronic inhalation exposures of narrow age groups of children.     

ASSESSING CONGRUENCEAMONG DISTANCE MATRICES: SINGLE-MALT SCOTCH WHISKIES REVISITED

A test of congruence among distance matrices is described. It tests the hypothesis that several matrices, containing different types of variables about the same objects, are congruent with one another, so they can be used jointly in statistical analysis. Raw data tables are turned into similarity or distance matrices prior to testing; they can then be compared to data that naturally come in the form of distance matrices. The proposed test can be seen as a generalization of the Mantel test of matrix correspondence to any number of distance matrices. This paper shows that the new test has the correct rate of Type I error and good power. Power increases as the number of objects and the number of congruent data matrices increase; power is higher when the total number of matrices in the study is smaller. To illustrate the method, the proposed test is used to test the hypothesis that matrices representing different types of organoleptic variables (colour, nose, body, palate and finish) in single‐malt Scotch whiskies are congruent.     

统计执法的博弈分析

针对目前中国统计数据失真相当严重并引起社会各界普遍关注的现象，运用博弈论作为分析工具，引入重复博弈研究了统计执法中数据报方与查方的利益冲突关系，从统计执法的角度揭示了统计数据失真的主要原因，并提出了相应的五项对策。     

论物权法的“生态化”

“物”和“环境”是两个内涵不同、价值取向差异巨大的概念;在环境危机时代下,需要变革物权,对其进行“生态化”的改造。物权法生态化的设计包括物权客体范围的扩张,物权法律关系内容的生态化,物权种类的生态化等方面。