Inferences on the Means of Two Log-Normal Distributions: A Computational Approach Test

In this article, we propose a novel approach for testing the equality of two log-normal populations using a computational approach test (CAT) that does not require explicit knowledge of the sampling distribution of the test statistic. Simulation studies demonstrate that the proposed approach can perform hypothesis testing with satisfying actual size even at small sample sizes. Overall, it is superior to other existing methods. Also, a CAT is proposed for testing about reliability of two log-normal populations when the means are the same. Simulations show that the actual size of this new approach is close to nominal level and better than the score test. At the end, the proposed methods are illustrated using two examples.     

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.     

Blinded continuous monitoring in clinical trials with recurrent event endpoints

In studies with recurrent event endpoints, misspecified assumptions of event rates or dispersion can lead to underpowered trials or overexposure of patients. Specification of overdispersion is often a particular problem as it is usually not reported in clinical trial publications. Changing event rates over the years have been described for some diseases, adding to the uncertainty in planning. To mitigate the risks of inadequate sample sizes, internal pilot study designs have been proposed with a preference for blinded sample size reestimation procedures, as they generally do not affect the type I error rate and maintain trial integrity. Blinded sample size reestimation procedures are available for trials with recurrent events as endpoints. However, the variance in the reestimated sample size can be considerable in particular with early sample size reviews. Motivated by a randomized controlled trial in paediatric multiple sclerosis, a rare neurological condition in children, we apply the concept of blinded continuous monitoring of information, which is known to reduce the variance in the resulting sample size. Assuming negative binomial distributions for the counts of recurrent relapses, we derive information criteria and propose blinded continuous monitoring procedures. The operating characteristics of these are assessed in Monte Carlo trial simulations demonstrating favourable properties with regard to type I error rate, power, and stopping time, ie, sample size.     

Modifications of sequential designs in bioequivalence trials

Bioequivalence (BE) studies are designed to show that two formulations of one drug are equivalent and they play an important role in drug development. When in a design stage, it is possible that there is a high degree of uncertainty on variability of the formulations and the actual performance of the test versus reference formulation. Therefore, an interim look may be desirable to stop the study if there is no chance of claiming BE at the end (futility), or claim BE if evidence is sufficient (efficacy), or adjust the sample size. Sequential design approaches specially for BE studies have been proposed previously in publications. We applied modification to the existing methods focusing on simplified multiplicity adjustment and futility stopping. We name our method modified sequential design for BE studies (MSDBE). Simulation results demonstrate comparable performance between MSDBE and the original published methods while MSDBE offers more transparency and better applicability. The R package MSDBE is available at https://sites.google.com/site/modsdbe/ . Copyright © 2015 John Wiley & Sons, Ltd.     

正式英语的语言特征

正式英语是人们在辩论、演讲、写作和各种仪式等正式场合中使用的标准英语。掌握正式英语的语体风格、词汇色彩和语法结构 ,对英语学习者提高语言交际水平 ,增强英语语感大有裨益     

自我效度对单词记忆的影响

采用班杜拉的自我效度理论,在大量实证调查的基础上,考察其与单词记忆的关系,为英语词汇教学提供启示.研究表明,较之其它认知或情感因素,自我效度能对学生的学习动机、目标及结果作出更准确的预测和解释.自我效度强的学生在记忆的规律性、记忆方法的技巧性及自我调控的科学性上都要明显优于效度弱的学生.     

有效词汇教学探讨

这篇论文旨在解决英语词汇教学方面的问题。在分析学生词汇习得的基础上和对教学法的回顾和讨论的基础上,论文得出了一些可考的观点。     

中日文化差异与日语教学

中日两国一衣带水,相互毗邻,有着两千多年的友好交往历史。在语言文字方面两国人民互相学习,相互影响,有不少相同、相似之处。但其中也有一些看似相同,实际上已经出现差异并具有特色的词汇和习俗,弄清这些词汇和习俗差异对我们学习日语和同日本人交流大有益处。尤其是在日语教学中,把这些词汇与习俗的异同及时渗透给学生,把中日文化的对比融入日语语言教学中,既可大大地活跃课堂气氛,又可提高学生的积极性和交际水平、应用能力。     

论英语词汇习得

词汇问题一直是影响英语学习者提高英语水平的主要障碍之一。从词汇量、词义的多样性与准确性、词义的文化内涵及专业英语词汇等角度分析,加强课外阅读、鼓励学生在教学语境之外运用生词,从而使其在英语学习中形成良性循环是解决问题的有效途径。     

"民官比"不是影响政治体制改革的重要因素

在政治体制改革中,公务员或国家干部人数的多少并不是一个关键因素,重要的是必须把政府的社会定位(包括角色、权力和责任)划分清楚。与世界各国相比较,我国197.69∶1(或116.27∶1)的“民官比”并不高,因此,今后的政治体制改革不需要再把精力集中在“精简”上,而应按邓小平的部署,首先把党政分开和权力下放的工作做好。毕竟“小政府”是指“政府权力受限制”,而非“人数更少”;“大社会”是指“社会权利更广泛”,而非“人数更多”。