Statistical considerations associated with a comprehensive regulatory framework to address the unmet need for new antibacterial therapies

At present, there are situations in antibiotic drug development where the low number of enrollable patients with key problem pathogens makes it impossible to conduct fully powered non‐inferiority trials in the traditional way. Recent regulatory changes have begun to address this situation. In parallel, statistical issues regarding the application of alternative techniques, balancing the unmet need with the level of certainty in the approval process, and the use of additional sources of data are critical areas to increase development feasibility. Although such approaches increase uncertainty compared with a traditional development program, this will be necessary to allow new agents to be made available. Identification of these risks and explicit discussion around requirements in these areas should help clarify the situation, and hence, the feasibility of developing drugs to treat the most concerning pathogens before the unmet need becomes even more acute than at present. Copyright © 2014 John Wiley & Sons, Ltd.     

伊朗核计划的动因及其影响

自伊朗秘密建造核设施的消息曝光之后,伊朗的核问题成为国际又一热点.本文介绍了伊朗核问题的由来,分析了伊朗现行核政策的意图以及"逆潮流而动"坚持现行核政策的依据,并进一步指出它对未来中东政治格局的影响.     

孙子制胜思想探析

孙子思想体系从内容构成的角度可以分为:孙子的"全胜"思想;孙子的认知规律;孙子的争胜原理。孙子的"全胜"思想是孙子思想的主题,以"不战而屈人之兵"实现目的或目标为其理论目标,追求最"效益"的合理过程为宗旨。孙子的认知规律的核心是"知彼知己"规律,它是孙子知胜和制胜的重要依据和前提。孙子的争胜原理是实现孙子理论宗旨的保障,它衍生于孙子的非对称制胜思想。要获得对抗事件的胜利,必定存在一个非对称的作用,孙子的制胜艺术就是寻找、选择、创造、利用某种非对称作用而获胜的艺术。     

20世纪中国意笔人物画变革纵观

结合20世纪的百年中国社会发展历程背景,以及每阶段中国美术论争的焦点问题,介绍有关中国意笔人物画现代化历程中的重要变革史实,评析中国意笔人物画在内容、形式和技艺发展中的理论和实践,对20世纪中国意笔人物画在不同历史阶段(具体分开创性试验期、探索性发展期和多样化繁荣期三个阶段)中的主要流派及其代表人物,进行分别阐述.     

经济人的过程哲学诠释--社会存在本体论的理论范型

20世纪70年发展起来的社会存在本体论,其实质是关系实在论.人与人之间的首要关系是社会关系.经济关系是社会关系的集中表现.体现经济本质的事件本体论是人的社会存在的元哲学解释.这恰恰是怀特海过程哲学的核心.把社会存在本体论与过程哲学联系起来是使后者走向现代性的正确渠道.21世纪之初,由小科布领军的过程哲学研究正在把这一研究引向深入.     

城市化进程中的城乡协调问题

由于目前在城市化进程中所面临的难题主要是城乡关系的统筹问题.因此,为了实现建立和谐社会的目标,必须采取多项措施进行城乡协调.     

Tabulating weighted sup-norm functionals used in change-point analysis

We introduce a number of weighted partial sum processes of which certain sup-norm functionals may be used, for example, to detect changes in the mean of independent observations. Their limiting distributions are derived mathematically, simulated and then tabulated. With this information, a detailed numerical investigation of the power of these functionals is carried out.* ^*Research mainly done while at Carleton University, partially supported by an NSERC Canada Grant of Miklós Csörg? at Carleton University, Ottawa. Also supported by the Austrian Science Foundation (FWF) under grant SFB#010 (‘Adaptive Information Systems and Modelling in Economics and Management Science’) while at Technische Universität Wien. ? ^?Research partially supported by an NSERC Canada Grant of Miklós Csörg? at Carleton University, Ottawa.      

A random cluster algorithm for some continuous Markov random fields

Based on a random cluster representation, the Swendsen–Wang algorithm for the Ising and Potts distributions is extended to a class of continuous Markov random fields. The algorithm can be described briefly as follows. A given configuration is decomposed into clusters. Probabilities for flipping the values of the random variables in each cluster are calculated. According to these probabilities, values of all the random variables in each cluster will be either updated or kept unchanged and this is done independently across the clusters. A new configuration is then obtained. We will show through a simulation study that, like the Swendsen–Wang algorithm in the case of Ising and Potts distributions, the cluster algorithm here also outperforms the Gibbs sampler in beating the critical slowing down for some strongly correlated Markov random fields.     

Bootstrap LR tests of stationarity,common trends and cointegration

This paper considers the likelihood ratio (LR) tests of stationarity, common trends and cointegration for multivariate time series. As the distribution of these tests is not known, a bootstrap version is proposed via a state- space representation. The bootstrap samples are obtained from the Kalman filter innovations under the null hypothesis. Monte Carlo simulations for the Gaussian univariate random walk plus noise model show that the bootstrap LR test achieves higher power for medium-sized deviations from the null hypothesis than a locally optimal and one-sided Lagrange Multiplier (LM) test that has a known asymptotic distribution. The power gains of the bootstrap LR test are significantly larger for testing the hypothesis of common trends and cointegration in multivariate time series, as the alternative asymptotic procedure – obtained as an extension of the LM test of stationarity – does not possess properties of optimality. Finally, it is shown that the (pseudo-)LR tests maintain good size and power properties also for the non-Gaussian series. An empirical illustration is provided.