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.     

雄安新区科技企业创新能力评价研究

科技企业是实现科技创新的驱动者和科技成果转化的重要载体,也是推动研究开发的重要参与者,科学评价科技企业创新能力有助于企业自身不断发展壮大。在分析国内外新区科技企业创新驱动发展相关理论研究的基础上,从研发投入、研发基础、研发效益和现代科技四个角度,运用层次分析法构建科技企业创新能力评价系统,并通过实证分析说明评价系统的可靠性;根据评价系统测算出现阶段雄安新区科技企业创新能力,通过与成熟新区科技企业的比较,发现其短板和不足,力图为决策者科学合理评价、管理科技企业创新发展提供有益参考。     

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.     

市场分割、政企关系与异地市场拓展

中国的市场仍旧存在某种程度的分割，如何突破这种市场分割到异地拓展市场是企业要考虑的现实问题。以前的研究主要是从省级层面或国家层面进行宏观分析。文章创新地从政企关系视角入手来考察市场分割情形下微观层面的企业异地市场拓展，也是首先把市场分割（和异地市场）分为省内（本市外）市场、省外市场和海外市场三个不同层面来研究的论文。用世界银行的调查数据从微观企业个体层面检验了企业异地市场拓展的可能。实证研究结果发现，市场分割确实阻碍了企业异地市场拓展，但这仅限于省内市场而不是省外市场。此外，市场分割是有方向性的，从地方保护主义严重的市场里走出来的企业更容易拓展异地市场，但此结论仅适用于国内市场拓展而不适用于海外市场拓展。良好的政企关系是有利于企业异地市场拓展的，但仅限于省外市场，对省内市场以及海外市场是无效的。文章解释了其中的原因，并分析了对于企业实践的启示。     

论我国中小企业的国际化经营

中小企业在国民经济中占有重要的地位.随着经济全球化和社会分工的发展,中小企业的国际化经营已成必然趋势.本文分析了我国中小企业国际化经营存在的问题,提出了相应的对策建议.     

家族企业上市研究及其治理对策

证券发行核准制的实施为我国家族企业的进一步发展创造了难得的发展机遇 ,通过发行上市 ,家族企业在筹措到巨额发展资金的同时 ,又出现了新的“一股独大”现象 ,并由此滋生了许多亟待规范和完善的问题。     

监理企业的综合评价与决策分析

根据层次分析法(AHP),分析如何选择最合理的监理企业,为评估准则和希望投标的监理企业构建了一个层次结构,提出了分析模型和计算方法,并给出了一个具体实例。在决策分析过程中,按综合权重大小排序,进行方案优选,为决策提供依据。该方法得出的评价结果直观,为择优决策中标监理企业提供一种科学的评价方法。     

发展市场中介组织促进中小企业人力资源开发

针对市场中介组织的发展现状及存在的问题 ,着重从组织形式和服务内容两个方面 ,研究了发展为中小企业提供人力资源开发服务市场中介组织的目标模式 ,并提出了发展该类中介组织的对策措施