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.     

An approximation of logarithmic functions in the regression setting

We consider a method of moments approach for dealing with censoring at zero for data expressed in levels when researchers would like to take logarithms. A Box–Cox transformation is employed. We explore this approach in the context of linear regression where both dependent and independent variables are censored. We contrast this method to two others, (1) dropping records of data containing censored values and (2) assuming normality for censored observations and the residuals in the model. Across the methods considered, where researchers are interested primarily in the slope parameter, estimation bias is consistently reduced using the method of moments approach.     

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。     

英文影片的中国方言版字幕翻译

2012年3D 版《泰坦尼克号》的华丽上映曾掀起影迷们对它的新一轮热捧。文章就同样备受中国观众喜爱的中国方言版《泰坦尼克号》为案例，结合功能目的论来探寻中国方言版字幕翻译的目的与性质，进而分析、总结英文影片字幕的中国方言版译制活动过程。     

章公祖师佛像跨国追索诉讼国际私法问题研究

从章公祖师佛像跨国追索诉讼主体资格问题切入,分析佛像的法律性质,探讨涉案物权准据法的确定及适用问题。该案原告应由阳春村全体村民担任。涉案佛像属于文物,建议村民在荷兰法院提起原物返还之诉。受案法院应当适用物权冲突法确定准据法,即可能适用中国内地、中国香港或荷兰法律。被告在购买时应当对涉案佛像来源产生合理怀疑,因此不构成“善意”;原告应尽可能搜集证据证明《荷兰民法典》规定的20年消灭时效因起诉而中断。依据《香港货品售卖条例》和中国内地物权法理论与实践,被告均不能取得系争佛像的所有权。     

当代资本主义经济停滞问题:制度结构与治理危机——基于积累的社会结构理论的分析

关于经济停滞问题的探讨是对马克思主义经济危机理论的传承。2008年金融危机爆发十余年,资本主义经济停滞趋于常态化。积累的社会结构理论从资本积累与支撑这一积累的制度环境之间的矛盾出发,发现了主流经济学探讨资本主义经济停滞所忽略的制度性因素。积累的社会结构学派沿着"中间层次"的路径,将2008年金融危机界定为系统性的结构危机,认为新自由主义SSA的失灵是此次经济停滞持续的原因。资本主义经济停滞引发欧美发达资本主义国家的社会治理危机升级,一系列政治、社会和文化危机不断加剧。积累的社会结构理论从微观层面深刻把握了资本主义制度转型的轨迹,但并未深入探讨开展根本的制度变革。在面临百年未有之大变局的时代境遇下,中国在参与全球治理的过程中不断探索并推动世界经济政治新秩序朝着更加公正、合理的方向发展。     

Risk Modeling of Interdependent Complex Systems of Systems: Theory and Practice

The emergence of the complexity characterizing our systems of systems (SoS) requires a reevaluation of the way we model, assess, manage, communicate, and analyze the risk thereto. Current models for risk analysis of emergent complex SoS are insufficient because too often they rely on the same risk functions and models used for single systems. These models commonly fail to incorporate the complexity derived from the networks of interdependencies and interconnectedness (I–I) characterizing SoS. There is a need to reevaluate currently practiced risk analysis to respond to this reality by examining, and thus comprehending, what makes emergent SoS complex. The key to evaluating the risk to SoS lies in understanding the genesis of characterizing I–I of systems manifested through shared states and other essential entities within and among the systems that constitute SoS. The term “essential entities” includes shared decisions, resources, functions, policies, decisionmakers, stakeholders, organizational setups, and others. This undertaking can be accomplished by building on state‐space theory, which is fundamental to systems engineering and process control. This article presents a theoretical and analytical framework for modeling the risk to SoS with two case studies performed with the MITRE Corporation and demonstrates the pivotal contributions made by shared states and other essential entities to modeling and analysis of the risk to complex SoS. A third case study highlights the multifarious representations of SoS, which require harmonizing the risk analysis process currently applied to single systems when applied to complex SoS.     

China’s Choice of Analytical Models for Its Anti-Monopoly Law

Modern analytical models for anti-monopoly laws are a core element of the application of those laws. Since the Anti-Monopoly Law of the People’s Republic of China was promulgated in 2008, law enforcement and judicial authorities have applied different analytical models, leading to divergent legal and regulatory outcomes as similar cases receive different verdicts. To select a suitable analytical model for China’s Anti-Monopoly Law, we need to consider the possible contribution of both economic analysis and legal formalism and to learn from the mature systems and experience of foreign countries. It is also necessary to take into account such binding constraints as the current composition of China’s anti-monopoly legal system, the ability of implementing agencies and the supply of economic analysis, in order to ensure complementarity between the analytical model chosen and the complexity of economic analysis and between the professionalism of implementing agencies and the cost of compliance for participants in economic activities. In terms of institutional design, the models should provide a considered explanation of the legislative aims of the law’s provisions. It is necessary, therefore, to establish a processing model of behavioral classification that is based on China’s national conditions, applies analytical models using normative comprehensive analysis, makes use of the distribution rule of burden of proof, improves supporting systems related to analytical models and enhances the ability of public authorities to implement the law.     

On the estimation of non linear functions in stochastic volatility models

Abstract

This paper focuses on the inference of suitable generally non linear functions in stochastic volatility models. In this context, in order to estimate the variance of the proposed estimators, a moving block bootstrap (MBB) approach is suggested and discussed. Under mild assumptions, we show that the MBB procedure is weakly consistent. Moreover, a methodology to choose the optimal length block in the MBB is proposed. Some examples and simulations on the model are also made to show the performance of the proposed procedure.     

为合法经营活动而侵犯公民个人信息的刑法规制

最高人民法院、最高人民检察院《关于办理侵犯公民个人信息刑事案件适用法律若干问题的解释》第六条对为合法经营活动而侵犯公民个人信息行为进行独立规制,是新型犯罪罪状表述抽象化与罪状解释具体化、信息时代信息价值多元化与危害行为多样化、现代社会犯罪治理精细化与刑法评价精准化的内在要求.为合法经营活动而侵犯公民个人信息行为相关规范要素中的“为合法经营活动”应理解为主观超过要素,“获利五万元”应作严格解释,“曾因侵犯公民个人信息”应作广义解释,“其他情节严重”应包括信息数量标准.