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.     

Inference and optimal design of multiple constant-stress testing for generalized half-normal distribution under type-II progressive censoring

The generalized half-normal (GHN) distribution and progressive type-II censoring are considered in this article for studying some statistical inferences of constant-stress accelerated life testing. The EM algorithm is considered to calculate the maximum likelihood estimates. Fisher information matrix is formed depending on the missing information law and it is utilized for structuring the asymptomatic confidence intervals. Further, interval estimation is discussed through bootstrap intervals. The Tierney and Kadane method, importance sampling procedure and Metropolis-Hastings algorithm are utilized to compute Bayesian estimates. Furthermore, predictive estimates for censored data and the related prediction intervals are obtained. We consider three optimality criteria to find out the optimal stress level. A real data set is used to illustrate the importance of GHN distribution as an alternative lifetime model for well-known distributions. Finally, a simulation study is provided with discussion.     

The context of employment discrimination: interpreting the findings of a field experiment

Although field experiments have documented the contemporary relevance of discrimination in employment, theories developed to explain the dynamics of differential treatment cannot account for differences across organizational and institutional contexts. In this article, I address this shortcoming by presenting the main empirical findings from a multi‐method research project, in which a field experiment of ethnic discrimination in the Norwegian labour market was complemented with forty‐two in‐depth interviews with employers who were observed in the first stage of the study. While the experimental data support earlier findings in documenting that ethnic discrimination indeed takes place, the qualitative material suggests that theorizing in the field experiment literature have been too concerned with individual and intra‐psychic explanations. Discriminatory outcomes in employment processes seems to be more dependent on contextual factors such as the number of applications received, whether requirements are specified, and the degree to which recruitment procedures are formalized. I argue that different contexts of employment provide different opportunity structures for discrimination, a finding with important theoretical and methodological implications.     

State work and the testing concours of citizenship

Anyone trying to be a citizen has to pass through a set of practices trying to be a state. This paper investigates some of the ways testing practices calibrate citizens, and in doing so, perform “the state.” The paper focuses on three forms of citizenship testing, which it considers exemplary forms of “state work,” and which all, in various ways, concern “migration.” First, the constitution of a “border crossing,” which requires an identity test configured by deceptibility. Second, the Dutch asylum process, in which “being gay” can, in certain cases, be reason for being granted asylum, but where “being gay” is also the outcome of an examination organized by suspicion. And third, the Dutch measurement of immigrants’ “integration,” which is comprised of a testing process in which such factishes as “being a member of society” and “being modern” surface. Citizenship is analyzed in this paper as accrued and (re)configured along a migration trajectory that takes shape as a testing concours, meaning that subjects become citizens along a trajectory of testing practices. In contributing both to work on states and citizenship, and to work on testing, this paper thus puts forward the concept of citizenship testing as state work, where “state work is the term for that kind of labor that most knows itself as comparison, equivalency, and exchange in the social realm” (Harney, 2002, pp. 10–11). Throughout the testing practices discussed here, comparison, equivalency, and exchange figure prominently as the practical achievements of crafting states and citizens.     

构建现代远程开放教育考试体系初探

现代远程开放教育是基于以学习者为中心的开放学习和个别化学习。我们应从素质教育的培养目标出发 ,依据现代考试测量理论 ,利用现代科技手段 ,建立现代远程开放教育考试体系 ,客观、准确地评价学习者的进步状况以及在学识、能力等方面达到的水平 ,使学习者在学习过程中不断自我完善 ,培养他们积极进取的精神     

对新课程实施中学生评价方法的哲学思考——标准化考试与档案袋评定的整合

评价既可能成为课程改革的动力 ,也可能成为其实施的障碍 ,它是课程改革成败的关键。为使基础教育课程改革达到预期目的 ,必须将评价改革作为课程改革的一个重要部分 ,探索出与新课程理念相一致的评价方法。目前国外较为流行的评价学生的方法是档案袋评定 ,这种评价理念与我国的新课程理念相一致 ,它强调学生参与 ,注重学生发展。然而档案袋评定能够作为标准化考试的替代评价法吗 ?笔者从不同哲学观进行分析 ,最后得到结论 :档案袋评定和标准化考试是看似对立、实质互补的两种评价方法 ,教师在实际评价中必须将两种方法结合运用     

探析蒙古考验婚史诗与好汉三项比赛

好汉三项比赛从萨满教祭祀仪式演变成为衡量好汉的价值标准之后 ,渐渐渗透于蒙古英雄史诗之中 ,在原有完成任务式考验婚史诗的基础上 ,出现了复合式考验婚史     

保障奥运食品安全 完善食品安全可追溯管理

近年来，食品安全成为全球热点问题之一，为解决食品安全问题，食品可追溯技术应运而生，只要一个条形码，就可追溯到食品的出产地、生长地甚至基因情况，食品有了自己的“身份证”。为保障奥运期间的食品安全，北京应加强食品安全管理，供应奥运食品将全部实行可追溯制度，用科技手段来为奥运会护航。     

Robust testing with generalized partial linear models for longitudinal data

By approximating the nonparametric component using a regression spline in generalized partial linear models (GPLM), robust generalized estimating equations (GEE), involving bounded score function and leverage-based weighting function, can be used to estimate the regression parameters in GPLM robustly for longitudinal data or clustered data. In this paper, score test statistics are proposed for testing the regression parameters with robustness, and their asymptotic distributions under the null hypothesis and a class of local alternative hypotheses are studied. The proposed score tests reply on the estimation of a smaller model without the testing parameters involved, and perform well in the simulation studies and real data analysis conducted in this paper.