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.     

试论教育现代化与加强中华民族凝聚力的关系

新时期,国内外政治、经济、科技发展所带来现代人民族精神家园的失落及东西方文明之间的冲突对中华民族凝聚力提出了新的挑战。教育现代化从国家的统一、政权的巩固、经济、传统文化的发展等方面,对形成与巩固中华民族凝聚力发挥着强大作用。在全球视野中发展本土文化是中华民族永葆凝聚力的动力源泉。     

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.     

高职院校国防教育工作初探

全面贯彻党的教育方针,坚持育人为本、德育为先,实施素质教育,提高教育现代化水平,培养德智体美全面发展的社会主义建设者和可靠接班人,办好人民满意的教育,是发展高等职业教育,实施科教兴国战略的目标。从提高学生素质,促进现代化建设的高度出发,对高职院校开展国防教育的意义、目的、时间、方式和方法等进行探讨,有益于高职院校学生的全面发展。     

PATTERN RECOGNITION VIA ROBUST SMOOTHING WITH APPLICATION TO LASER DATA

Nowadays airborne laser scanning is used in many territorial studies, providing point data which may contain strong discontinuities. Motivated by the need to interpolate such data and preserve their edges, this paper considers robust nonparametric smoothers. These estimators, when implemented with bounded loss functions, have suitable jump‐preserving properties. Iterative algorithms are developed here, and are equivalent to nonlinear M‐smoothers, but have the advantage of resembling the linear Kernel regression. The selection of their coefficients is carried out by combining cross‐validation and robust‐tuning techniques. Two real case studies and a simulation experiment confirm the validity of the method; in particular, the performance in building recognition is excellent.     

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.