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.     

FDI的工资效应研究——基于江苏省制造业面板数据的分析

利用江苏省制造业2000--2006年的面板数据，从行业角度分析FDI对于江苏省制造业平均工资以及国有企业工资的影响，结果表明外资企业的进入可以通过提高整体的劳动生产率水平从而间接提高整体平均工资水平；劳动力工资与加工贸易的开放程度之间呈正相关关系，而与行业规模大小呈负相关．外资对于国有企业劳动力工资存在正的工资溢出，但是国内资本对于劳动力工资水平的影响与外商直接投资相比相差不大，甚至可以超过外商直接投资的贡献。     

南京国民政府时期南洋侨教政策负面影响述评

由于历史和现实的缘故，国民政府十分关注海外华侨尤其南洋华侨的教育，形成了比较完善的华侨教育体系，学校和学生数量呈上升趋势，学生素质也不断提高。然而由于国民政府侨教政策自身固有的弊病，给南洋侨教带来了相当的消极作用，限制了南洋侨教事业的进一步发展。     

葬礼:面对死亡的社会安排 ———城市环境下葬礼仪式浅析

通过实地观察和对殡仪馆工作人员的访谈，描绘了天津市城市内部现有的国家规范框架下葬礼仪式的具体过程以及附着在这个框架下的民间习俗的现状，试图通过对国家规范框架下的“正式”葬礼仪式及与其相对的“非正式”仪式——家庭告别仪式的程序形式的简略描述，展现在城市中普通个人的葬礼基于公共环境和家庭环境不同场景所采用的不同仪式过程。这是民间习俗对规范仪式的补充，同时也是“正式”规范对这种“非正式”实践的通融和消化。在描述现状之外，作者试图讨论蕴含在葬礼仪式中，不同死亡个体的葬礼仪式形式、规模及参与者等方面的区分所展现出的一种社会对死亡个体生前所处社会结构地位的认同，这种认同不仅反映了仪式所处社会背景的秩序和结构，也强化了这个社会的秩序和价值判断标准。     

"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”。     

《论语》释名辨正及《学而篇》校释考异

古今《论语》释名之分歧主要在“论”字上，对“论”的解释达八种之多，其中唯章太炎的“论”作“仑”说合乎历史实际。古今对《学而篇》的校勘、解释亦不乏分歧，故略作考察辨正：对“学而”章应作整体性、连贯性解释；“为仁之本与”之“仁”作“人”；“传不习乎”之“传”的本字为“专”；“贤贤易色”句意即“贤贤”“修然”；“主忠信，无友不如己者”句意即君子忠信，不与不忠不信的人交朋友。