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.     

“台湾老兵”的婚姻状况调查及原因分析——以浙江籍“台湾老兵”为个案

“台湾老兵”问题是历史留存于海峡两岸的中国社会的特殊问题，而婚姻问题又是“台湾老兵”中最突出的问题。文章以浙江籍“台湾老兵”为个案，调查了他们去台湾前后的婚姻状况，并分析了造成大多数“台湾老兵”在台湾孤单度过大半辈子、甚至一辈子的原因。     

中国人口性别结构的区域差异及演变动态分析

人口性别构成是影响人类婚姻、人口再生产的基本因素，也影响国家经济、政治、文化、教育等方面的发展，也是编制经济、文化、教育、科技、卫生、人民生活、劳动、城乡建设等发展规划的重要依据。同时对于中国当前正在进行的和谐社会建设也具有重要意义。利用中国五次人口普查资料及2005年1％人口抽样资料分析了中国总人口性别比演变动态及地理分布特征。表明：（1）中国在历史上是一个性别比偏高的国家，新中国总人口性别比呈下降趋势；（2）1953到2005年，年龄性别比曲线越来越平稳，性别比最高峰值呈现有低龄组向中龄组及高龄组转移的趋势；（3）各省区之间及城乡之间的性别结构差异由大变小；（4）山区性别比高于平原。重工业城市高于其他城市。大城市高于小城市。     

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.     

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.     

If you look like me,I'll talk to you: a preliminary study of ethnic identity and inter‐ethnic interaction among women in Singapore

In Singapore, government policy is for equal but separate development of the four major ethnic groups—Chinese, Malay, Indian and other. In this study, I attempt to gain some preliminary views of how strongly women identify with their own ethnic group and how freely they are prepared to interact with people from other ethnic groups in non‐work‐related situations. I confine my study to females for two reasons. One is that traditional ethnic dress is common among females in Singapore but much rarer among men, and this makes a strong non‐verbal statement of identity. The second reason is to avoid differences between males and females, which I did not wish to pursue within the limits of this exploratory study. The findings of my pilot investigation indicate that intra‐ethnic spontaneous interaction is more likely to occur among women who display a strong national identity. Moreover, younger women, who were exposed during their school years to the government's recent drive to nurture ethnic and cultural differences, are less open to inter‐ethnic interaction than are women in their 30s and older, who grew up when the government drive was towards creating one common national identity for the people of Singapore.     

关于第三者损害婚姻赔偿责任问题的再探讨

婚姻是受法律保护的民事法律关系,其绝对权的性质决定了任何人不得侵犯,第三者介入他人婚姻的行为侵害了无过错配偶方的配偶权,给其造成了人身和财产的损失,根据我国法律及世界其他国家和地区的法律与做法,第三者必须承担损害婚姻赔偿责任。