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.     

在现代性与后现代性之间——论20世纪90年代先锋诗歌观念的演进

在现代性与后现代性的张力关系中展开是20世纪90年代中国先锋诗歌观念的重要走向之一。这样的走向当中包含了对于诗歌观念与诗学理论的较为复杂的思考,而西方的现代性与后现代性的理论话语在提供其强大的思想动力与观念支持的同时,本身也不同程度地处于被偏离与改写的过程中。这有可能指向某种本土化观念建构与诗学话语的独立和对于当代诗歌的历史本质的深度把握。     

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.     

丁玲与延安文艺

对于丁玲来说,生命的辉煌与劫难都与延安文艺时代密不可分,延安文艺时代成就了丁玲,也为其以后的劫难埋下了伏笔。通过丁玲与延安文艺的建构、碰撞、融合关系的梳理,不难看出丁玲为延安文艺的建构、发展做出了重大贡献,但同时由于丁玲自身个性主义与政治意识的纠结也在无意间对延安文艺的一体化发展带来了一定程度的阻滞。     

关系营销视角下的渠道冲突机理与规避研究

分销渠道畅通与否，直接影响企业在市场上的竞争能力和经营业绩。因此，正视分销渠道管理中的矛盾冲突，深入分析其特点及产生机制并对症下药，对企业的经营具有重要意义。本文另辟蹊径，从关系营销的视角对其进行了深入的研究。     

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.     

Who Gets What From Government? Distributional Consequences of Child‐Care Assistance Policies

Given the fragmented structure of child‐care assistance in the United States, it has been difficult to obtain accurate estimates of which families are assisted, through which mechanisms, and at what level. Making use of survey data from New York City, we analyze the distribution of several forms of public child‐care assistance. Results suggest that about 40% of all families with young children receive some form of child‐care assistance. Considering all forms of assistance, the distribution of child‐care help is targeted in both expected and some unexpected ways. Implications of these results are discussed in the context of U.S. child‐care policies governing access and benefit levels.