Issues in applying recent CPMP ‘Points to Consider’ and FDA guidance documents with biostatistical implications

The International Conference on Harmonisation guideline ‘Statistical Principles for Clinical Trials’ was adopted by the Committee for Proprietary Medicinal Products (CPMP) in March 1998, and consequently is operational in Europe. Since then more detailed guidance on selected topics has been issued by the CPMP in the form of ‘Points to Consider’ documents. The intent of these was to give guidance particularly to non‐statistical reviewers within regulatory authorities, although of course they also provide a good source of information for pharmaceutical industry statisticians. In addition, the Food and Drug Administration has recently issued a draft guideline on data monitoring committees. In November 2002 a one‐day discussion forum was held in London by Statisticians in the Pharmaceutical Industry (PSI). The aim of the meeting was to discuss how statisticians were responding to some of the issues covered in these new guidelines, and to document consensus views where they existed. The forum was attended by industry, academic and regulatory statisticians. This paper outlines the questions raised, resulting discussions and consensus views reached. It is clear from the guidelines and discussions at the workshop that the statistical analysis strategy must be planned during the design phase of a clinical trial and carefully documented. Once the study is complete the analysis strategy should be thoughtfully executed and the findings reported. Copyright © 2003 John Wiley & Sons, Ltd.     

An affine‐invariant multivariate sign test for cluster correlated data

The author presents a multivariate location model for cluster correlated observations. He proposes an affine‐invariant multivariate sign statistic for testing the value of the location parameter. His statistic is an adaptation of that proposed by Randles (2000). The author shows, under very mild conditions, that his test statistic is asymptotically distributed as a chi‐squared random variable under the null hypothesis. In particular, the test can be used for skewed populations. In the context of a general multivariate normal model, the author obtains values of his test's Pitman asymptotic efficiency relative to another test based on the overall average. He shows that there is an improvement in the relative performance of the new test as soon as intra‐cluster correlation is present Even in the univariate case, the new test can be very competitive for Gaussian data. Furthermore, the statistic is easy to compute, even for large dimensional data. The author shows through simulations that his test performs well compared to the average‐based test. He illustrates its use with real data.     

Sport and globalization: transnational dimensions

Abstract The aims of this special issue are to both raise the social scientific status of sport and to advance understanding of transnational processes through the role of sport in global change. The Introduction argues that sport, like globalization, can be understood in transdisciplinary terms, and the papers included contributions informed by sociology, anthropology, political sciences and history. As well as placing the issue in the context of recent studies of sport and globalization, the Introduction outlines the seven papers. Placed together they move from analyses of broader globalizing and multi‐sport issues towards consideration of how transnational processes impact upon individual sports – with examples from cricket, baseball and association football – ending with regional and national dimensions.     

State‐led transnationalism and migration: reaching out to the Argentine community in Spain

Abstract This article focuses on when and how states develop transnational policies. It presents a case study of a relatively small emigrant community, whose departure was not simply caused by poverty or crisis, but most recently by an economic and political debacle that questioned people's values and expectations. I focus on the state side of the equation and identify a shift in Argentina's policy after 2003, though also show how such policies came out of a long history of state intervention in population and migration and are now related to human rights concerns and the unfinished process of democratic consolidation. I argue that the state initiates political transnationalism, not migrants, and highlight the importance of some relatively unexplored factors in the understanding of the motivation, intensity and impact of the state's involvement, such as the characteristics of the emigrant community, the existence of specific political projects, the role of some domestic actors and processes, and the nature of international agreements.     

诠释学与比较文学的发展

互动认知研究的空间是变动、开放、动态的空间。双向诠释即是首先了解对方,然后从对方的角度和视野来观察和进一步了解自己,使双方对自己和对方都有了新的认识。重视从“他者”反观自身的理论逐渐为广大理论界所接受。一些非汉学家的理论家开始以一种“非中心论”的心态来探讨西方和非西方文化,并以此为基础建构新的理论,这就从根本上动摇了西方中心论的基石。比较文学和比较文化研究迅速突破了封闭的西方文化体系,进入西方文化与非西方文化相互参照的范围。西方学术界原来互不相干的汉学研究、文学理论研究、比较文学研究正在迅速靠拢,并实现互补、互识、互证。     

Bayesian locally optimal design of knockout tournaments

The elimination or knockout format is one of the most common designs for pairing competitors in tournaments and leagues. In each round of a knockout tournament, the losers are eliminated while the winners advance to the next round. Typically, the goal of such a design is to identify the overall best player. Using a common probability model for expressing relative player strengths, we develop an adaptive approach to pairing players each round in which the probability that the best player advances to the next round is maximized. We evaluate our method using simulated game outcomes under several data-generating mechanisms, and compare it to random pairings, to the standard knockout format, and to two variants of the standard format.     

A bayesian estimator for the dependence function of a bivariate extreme‐value distribution

Any continuous bivariate distribution can be expressed in terms of its margins and a unique copula. In the case of extreme‐value distributions, the copula is characterized by a dependence function while each margin depends on three parameters. The authors propose a Bayesian approach for the simultaneous estimation of the dependence function and the parameters defining the margins. They describe a nonparametric model for the dependence function and a reversible jump Markov chain Monte Carlo algorithm for the computation of the Bayesian estimator. They show through simulations that their estimator has a smaller mean integrated squared error than classical nonparametric estimators, especially in small samples. They illustrate their approach on a hydrological data set.     

莫泊桑短篇小说中的第一人称叙述

莫泊桑的短篇小说堪称一绝,在叙事上独具特色。与其他现实主义作家不同,莫泊桑喜欢采用第一人称叙述,他笔下的叙述者"我"并非都是全知全能,大部分叙述者权利有限。更为独特的是,他在这类作品中首创的叙述分层的手法,使得人物成一种对话关系。他对叙述者权利的限制使得作品意义留有空白。叙述语调的中立要求读者积极参与作品意义的建构,这极大增强了短篇小说的可读性,也使他的作品带有现代主义的气息。     

学习贯彻十六大精神,推进“两课”教育教学的创新

学习贯彻十六大精神,推进“两课”教育教学的创新@赵书爱$华北水利水电学院人文社科部!河南郑州450011     

Block external bootstrap in partially linear models with nonstationary strong mixing error terms

The authors extend the block external bootstrap to partially linear regression models with strongly mixing, nonstationary error terms. In addition to providing an approximate distribution for the semiparametric least square estimator of the parametric component, they propose a consistent estimator of the co‐variance matrix of this estimator.