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.     

Ethnicity, migration and health: A population-based study of 338 refugees from Latin America, 396 nonrefugee immigrants from Finland and 161 from southern Europe and 996 age-, sex- and education-matched controls from Sweden

This article shows the influence of being a refugee from Latin America or a nonrefugee immigrant from southern Europe or Finland on self-reported illness, controlling for social factors and lifestyle. The study population consisted of 338 Latin American refugees, a random sample of 396 Finnish and 161 southern European immigrants and 996 age-, sex- and education-matched Swedish controls. The data were analysed unmatched with logistic regression (multivariate analysis) in main effect models. The strongest independent risk indicator for long-term illness was being a Latin American refugee (estimated odds ratio (OR)=2.96, 95% confidence interval (CI)=2.19–3.82). There was a significant association between being a Latin American refugee and period prevalence, ill health and unsatisfied need for care. Being a southern European or Finnish immigrant was a risk indicator of ill health but was not associated with the other dependent factors. Not feeling secure in daily life was a strong risk indicator for long-term illness and ill health (estimated OR=1.89, 95% CI=1.26–2.76 and OR=3.04, 95% CI= 1.97–4.48) respectively). Being a Latin American refugee was equal in importance to traditional risk factors such as overweight and not taking regular exercise for long-term illness and ill health.     

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。     

恩施自治州行政执法状况调查与分析

依法行政是依法治国的主要任务和关键所在。通过对恩施自治州的行政执法状况进行调查,结果表明:恩施自治州的行政执法在总体上是好的,但也存在诸多问题。     

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。     

Olive Oil Consumption in Greece: A Microeconometric Analysis

In this paper, the factors affecting at-home demand for three types of oils and fats in Greece, with emphasis on olive oil, are investigated using the linear approximation of the Almost Ideal Demand System and family budget survey data. To overcome the econometric problem created with the existence of zero expenditure, a generalization of the two-stage Heckman procedure is employed. In order to investigate the role of self-consumption, two different samples were used. The first includes all households; the second excludes those that acquire olive oil only from own production. According to the results, there are important differences in the first stage of the decision process between the two samples. Unlike the first stage, the second stage of the decision process found no important differences between the results for the two samples.     

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。     

最近10年来陶行知热点问题研究概观

当代陶行知研究的基本特点是以生活教育为中心,从理论研究走向实践探索,加强了国内与国外的联系,呈现出一种历史研究与现实借鉴、理论探讨与实践总结有机结合、互补共进的新局面。建国后,人们一直在争论的几个基本理论问题,到20世纪90年代已不再是人们的关注热点。现在学术界展开热烈讨论的问题主要有生活教育理论、创造教育思想、陶行知与中外文化教育、陶行知教育思想与当代中国教育的改革和发展等。