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.     

文学史的核心价值与古今演变

本文着重分析在过去的文学史研究中古代与现代相互隔绝的成因与弊病 ,提出从重新阐释中国文学的历史与传统入手 ,沟通古今文学 ,研究其演变的过程 ;提出文学史的核心价值是文学与人性发展的关系、文学在此发展过程中的作用 ,并主张以此核心价值为主线来研究古今文学之演变。     

Sample size re‐estimation incorporating prior information on a nuisance parameter

Prior information is often incorporated informally when planning a clinical trial. Here, we present an approach on how to incorporate prior information, such as data from historical clinical trials, into the nuisance parameter–based sample size re‐estimation in a design with an internal pilot study. We focus on trials with continuous endpoints in which the outcome variance is the nuisance parameter. For planning and analyzing the trial, frequentist methods are considered. Moreover, the external information on the variance is summarized by the Bayesian meta‐analytic‐predictive approach. To incorporate external information into the sample size re‐estimation, we propose to update the meta‐analytic‐predictive prior based on the results of the internal pilot study and to re‐estimate the sample size using an estimator from the posterior. By means of a simulation study, we compare the operating characteristics such as power and sample size distribution of the proposed procedure with the traditional sample size re‐estimation approach that uses the pooled variance estimator. The simulation study shows that, if no prior‐data conflict is present, incorporating external information into the sample size re‐estimation improves the operating characteristics compared to the traditional approach. In the case of a prior‐data conflict, that is, when the variance of the ongoing clinical trial is unequal to the prior location, the performance of the traditional sample size re‐estimation procedure is in general superior, even when the prior information is robustified. When considering to include prior information in sample size re‐estimation, the potential gains should be balanced against the risks.     

And I Still Love Them: On Touching Loss

In this article, the author performs a re‐membering practice that incorporates a relational materialist theory. It traces the disturbances that follow in the wake of three deaths in her family. Written in an autoethnographic voice, the article is a polyphonic composition of the narrative therapy approach of re‐membering entangled with the spacetimematter of silence, speaking, sitting, staying, presence, absence, loss of momentum, dreams, trees, books, cardiac pace‐makers, writing, breath, ashes, murmuring, suffering. Thus, the dispersed agencies of bodies, human and non‐human, reinvigorate a linguistic practice and the author's personal and professional life.     

A not so strange silence: Why qualitative researchers should respond critically to the qualitative data archive

A driving force behind the establishment of a qualitative data archive in the United Kingdom has been the oral historian, Paul Thompson. He has complained that there is a ‘strange silence’ among qualitative sociologists on re‐analysis, and that many have been reluctant to deposit data. The first part of the paper suggests that the common ethical and practical objections can be overcome in establishing an archive in Australia. However, there is a more serious underlying ideological objection: that archiving promotes and institutionalises a narrow empiricist version of qualitative research. The rest of the paper makes this case by examining teaching materials on a British website, by reviewing Thompson's arguments, and by considering some examples of re‐analysis by sociologists. It is argued that qualitative researchers should respond critically, but that it is possible to address and overcome these problems when developing an Australian archive.     

王韶《平戎策》中处理民族关系的原则及借鉴意义--兼补辑《全宋文》中的王韶文

王韶是北宋神宗朝开拓熙河而立下赫赫战功的大军事家、政治家.其<平戎策>提出了恩信招抚、汉法教化、平等相待、杂居互学、发展经济等处理民族关系的原则,在今天仍具有借鉴意义.另为<全宋文>补辑王韶文五篇.     

Monstrosities and moral publics

Interdisciplinary scholarship on neoliberal urban governmentality has been attentive to the knowledges and techniques of government currently emerging at the interface of local state politics and invested claims of voluntary private actors such as corporate partners and philanthropic agencies. This article draws attention to the workings of the aesthetic as an epistemological grounding for the rationalization of urban rule. Specifically, I explore a Toronto, Canada-based philanthropic agency’s reliance on a mise-en-scene of urban terror to animate its own self-validated knowledges about targeted inner-suburban subjects and spaces. In their circulation and demand for public address, the agency’s graphic public service announcements, launched in 2007, herald what I argue is a moralized set of knowledges about municipal renewal that has its own normative orientations grounded in a neoliberal political rationality, and tangentially, in racialized security imperatives. I detail various dimensions of the social life of a video associated with this public service campaign targeting ‘youth at risk’, considering the ethical, political and economic valences it was expected to convey; its semiotic exchange with other images and representations of disenfranchised spaces, subjects and communities; and the publics it attempted to interpellate. Importantly, given the agency’s current standing as a prominent player in Canadian urban policy arenas, I pay analytical attention to the visual campaign as a site for the production of knowledges about proper urban citizenship and social governance, and as such, a strategic-orienting device for urban policy interventions and directives.     

创新理念 推进自治制度运行和自治地方治理现代化

Deepening reform, promoting the rule of law, and implementing the “Five Develop￣ment ” concepts have had a deep influence on the modernization of governance in ethnic autonomous regions. Based on a review of 30 years of success￣ful experiences in implementing ethnic regional au￣tonomous law, and focusing on the concepts of“innovation, coordination, green development, openness and sharing”, we need to conduct in -depth research on the ways to:promote governance by law, realize the modernization of governance;and promote the efficient implementation of ethnic autonomous systems in the ethnic autonomous re￣gion.
The 155 ethnic autonomous areas of China cover 64% of the total area of the country. There￣fore, the governance of the country cannot be a￣chieved without modernizing the governance in the ethnic autonomous regions. Modernizing the gov￣ernance in ethnic autonomous regions is a necessa￣ry element for modernizing the governance of the nation. The modernization of the ethnic autono￣mous regions actually means the legalization of the governance in ethnic autonomous areas, which is a main part of the legalization of the ethnic affairs.
The comprehensive, deepening of reform, and promoting governance by law have been strongly promoted. We should start from reality, respect differences, and take the development concepts of“innovation, coordination, green, openness and sharing” into consideration so as to promote the ef￣ficient implementation of ethnic regional autono￣mous systems through various methods. We should update our concepts, weaken specificity, solidify locality, intensify new thinking, innovate the run￣ning of ethnic autonomous systems, and promote the modernization of governance in ethnic autono￣mous regions. Based on a comprehensive analysis of the theories and practices used since the imple￣mentation of ethnic regional autonomous regula￣tions, and under the premise of intensifying “the legalization of ethnic affairs”, we should deepen the comprehensive reform of the ethnic autonomous regions, comprehensively promote the governance by law, and realize the goal of building a moder￣ately prosperous society as scheduled through im￣proving and innovating the running of ethnic re￣gional autonomous systems.
“Ethnic areas are districts with rich resources and water sources; they are ecological screen zones, cultural characteristic zones, border areas, and poor areas.” At the same time, due to histori￣cal, social and natural factors,“the natural condi￣tions of most ethnic areas are not good; their be￣ginning phase of development is low; they have many historical debts; they are located far away from the central markets and urban areas;their ur￣ban-rural gap is very obvious”, and “their gap with the eastern areas ( of China) is growing larger and larger”. The reform and the promotion of gov￣ernance by law in ethnic autonomous areas should put more emphasis on locality, ethnicity and “au￣tonomy”. Of course, we must avoid of “artificial￣ly” intensifying ethnic consciousness, and creating ethnic “differences”. Meanwhile, we should “im￣prove the capability for legal management of ethnic affairs”, “intensify the construction of laws and regulations related to ethnic work”, “legally han￣dle those issues involving ethnic factors”, “insist on resolving issues involving ethnic factors by the law, and avoid of regarding civil and criminal problems related to ethnic people as ethnic prob￣lems, or regarding common disputes in ethnic are￣as as ethnic problems. ”
We should affirm that China’s ethnic relations are harmonious, and that their economics are de￣veloping rapidly. Since the implementation of the policy of “reform and opening -up”, especially since 2005 , the economics in ethnic autonomous regions have developed dramatically; the people’s living conditions have continuously improved;bas￣ic infrastructure has significantly speeded up; and ecological protection has solidly improved. Howev￣er, the problems still prevail. For example, the poverty in ethnic areas is still serious—there are more than 25 million poor in ethnic rural areas. Therefore, the task of poverty alleviation is still very tough. In addition, the gap between urban and rural areas and between different regions is very large in ethnic autonomous regions. Finally, the rate of urbanization is very low.
In sum, during the process of modernizing so￣cial governance in ethnic autonomous regions, we must pay full attention to the five“stage character￣istics” of ethnic work in China which are the:( i) co - existence of opportunities and challenges brought by the “reform and opening -up” policy and the socialist market economy;( ii) co-exist￣ence of the state’s constant support to the ethnic ar￣eas and its low level of development; ( iii ) co -existence of the state’s constant support to the eth￣nic areas and the weak level of basic public service capability in ethnic areas; ( iv ) co -existence of the constant exchange and fusion between various ethnic groups and the disputes involving ethnic fac￣tors;and ( v) co-existence of the great achieve￣ments in anti-national splittism, religious extrem￣ity, and violent terrorism, as well as the active ter￣rorism activities in some areas. Only when we rec￣ognize this situation, can we understand the speci￣ficity of doing ethnic work in China. The innova￣tion of governance of ethnic autonomous areas and the promotion of governance by law in the whole country must start from this actual situation.
At present, we still need to clarify the conno￣tations of autonomous rights. Based on a clear clar￣ification of the basic meaning of ethnic regional au￣tonomous rights, we should deepen reform, active￣ly transform the governance of the ethnic autono￣mous regions, further deepen relevant theoretical studies, and positively promote the ethnic regional autonomous system. The main purpose of the eth￣nic regional autonomous areas is to promote the de￣velopment of the various affairs of ethnic minorities and ethnic regional autonomous areas. The purpose for improving the ethnic regional autonomous sys￣tem is to ensure the development of ethnic minori￣ties and ethnic regional autonomous regions. Im￣proving the ethnic regional autonomous system should transform from one of preferential treatment to one of nuanced development.
Looking back to the past, the legal construc￣tion of ethnic regional autonomy has made great a￣chievements. However, the preferential policies of the state and relevant institutes are still the real factors promoting the development of the various af￣fairs of the ethnic minorities and ethnic autonomous areas. As described in this article, there are multi￣ple factors which influence the efficiency and per￣formance of the ethnic regional autonomy. The eth￣nic autonomous regions are restricted by natural conditions and economic development, therefore, they have to depend on assistance from the state and the relevant institutes—this is the objective re￣ality. However, the improvement of the ethnic re￣gional autonomous system must change the status of the past, and enable the ethnic regional autono￣mous system play out its actual role so that the va￣rious affairs of ethnic minorities and ethnic autono￣mous regions can step onto a road of nuanced de￣velopment.
The future development of the ethnic regional autonomous system depends on the consensus of theoretical and practical circles, i. e. a long-term mechanism whose purpose is to enable the system itself play its actual role should be established. Only by such a mechanism, can these puzzling problems be solved and gradually improved. Tak￣ing the breakthrough of the actual effect of the sys￣tem as the starting point of the ethnic regional autonomy’s deepening of the reform, one should take the following aspects into consideration:1 ) re-examine existing laws and regulations, and im￣prove them on the basis of institutional norms, en￣hance normalization, uniformity and manipulability of the ethnic regional autonomous regulations; 2 ) sort out the relationship between the institutions in ethnic autonomous areas and the upper levels of the state institutes, as well as the relationship be￣tween the institutions on the same level;on the va￣rious institutional levels, enhance clear cognition on the position, role and organizing principles of the ethnic regional autonomous system, and avoid taking the ethnic regional autonomous system as the affairs of the ethnic autonomous areas;3 ) im￣prove the supervisory mechanisms for running the ethnic regional autonomous system; and 4 ) im￣prove the mechanisms for handling disputes on the running of the ethnic regional autonomous system.
We must work closely, share the achieve￣ments, and promote the operation of the ethnic re￣gional autonomous system. For this purpose, we should:1 ) standardize the management of the eth￣nic regional autonomous system, and weaken the“specificity”;2 ) promote the governance capabili￣ty of the ethnic regional autonomous areas, and so￣lidify the concept of“locality”;3 ) enhance auton￣omous awareness and capability, intensify “new thinking”, motivate initiatives from the autonomous areas, and improve the autonomous system from the bottom-up, and rationally allocate the power and rights of the high-level organs and the auton￣omous organs in the ethnic autonomous areas.     

Fuites,droit et liberté d'expression: la loi peut‐elle promouvoir les dénonciations dans l'intérêt général?

Les auteurs examinent la différence entre fuites et alertes, ou dénonciations, notamment quant à la protection de leurs initiateurs. A ce propos, ils étudient les dispositions des conventions internationales sur les droits de l'homme et la corruption, ainsi que les textes en vigueur en Allemagne, aux Etats‐Unis, en France et au Royaume‐Uni. Leurs résultats mettent en évidence la complexité et les contradictions des questions en jeu: intérêt général et intérêts individuels, commerciaux et financiers; abus de pouvoir; sécurité et confidentialité face à la communication électronique; place de l'individu dans l'application de la loi; relations d'emploi.     

转型期我国职工下岗问题的社会学分析

企业职工大规模下岗是我国转型期特有的经济社会现象.从社会学视角看,下岗实质上是失业,必然产生多重社会效应.再就业工程作为政府动员社会资源解决下岗失业问题的应急措施,不可能长期搞下去,必须着眼于劳动力市场的发育和完善,寻找市场、政府和社会三方面的结合点,这是解决下岗失业问题的治本之策.