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.     

当代中国的音乐及社会差序——京剧票友会与摇滚乐队“派对”比较研究

本文主要探讨当代中国的两种音乐活动形式——京剧票友会以及摇滚乐队派对。这两种音乐形式虽然在风格上截然不同,但是两种社团在结构上却存在着一定的相似性。这两种活动形式基本上都具有我们所称之为＂为位＂（positioning）的行为,参与者由此在音乐活动中找到他们各自的位置。而且,两种活动形式都涉及到＂外来者的融入＂（outsider integration）,即允许陌生人的参与并在活动中找到他们的位置。     

Being Judged,Being Assessed: Young People’s Perspective of Assessment in Youth Justice and Education

Research from the Economic and Social Research Council programme on Pathways Into and Out of Crime prioritised young people’s ‘voices’ in exploring experiences of crime and a range of intervention services. Drawing on data from interviews with 110 young people, this paper explores their perspectives of professional assessment. Embedded within neo‐liberal youth welfare policies are a number of contradictions. Policies encourage ‘individualisation’, ‘responsiblisation’ and ‘self‐realisation’ while also needing to maintain control and regulation of ‘risky’ populations. This paper explores the implication of these contradictions through examining the experiences of young people being assessed in youth justice and education. The impact on their identities as neo‐liberal citizens is discussed in the conclusion.     

The problem of social generations: a critique of the new emerging orthodoxy in youth studies

Over the previous seven years the application of a social generation paradigm or ‘theory’ has gained increasing currency as a method in analysing young people's relationship with the life course. Whilst not a new concept or approach its resurgence and reconfiguration to ‘new’ times has seen some writers positioning it as a ‘new orthodoxy’ or ‘consensus’ within youth studies. In this it is seen as providing a conceptual framework that better helps us understand the complexity of circumstances and conditions that shape youth identities in late modern society. In this paper we examine and explore the underlying assumptions and claims that are made by those advocating the social generational paradigm, raising questions and seeking further clarification on a number of key themes. We accept youth studies needs to move beyond ‘old models’ that define and understand social context as a simply a tension between ‘structure or/and agency’ or as a ‘flavour’ to social action. To conclude therefore we propose the need to have an approach that is ecological and both accepts ‘social change’ and ‘continuity’ as critical parts of the life course, one that recognises the nature and influence of power and social reproduction, especially for different social classes, in shaping the experience of being young.     

Child custody issues and co‐occurrence of intimate partner violence and child maltreatment: controversies and points of agreement amongst practitioners

The situation of families undergoing separation in a context of co‐occurrence of intimate partner violence (IPV) and child maltreatment raises certain issues related to child custody. The results presented in this paper were collected and analysed within the framework of a qualitative study aiming to identify the principal points of agreement and the main controversies amongst practitioners in several different types of organizations. Focus groups were held with a total of 43 practitioners from six different settings concerned with child custody in cases of co‐occurrence of IPV and child maltreatment. Although they agreed on the importance of ensuring the safety of victims of violence, their views diverged on three points: (1) the importance of preserving the father–child relationship; (2) collaboration between voluntary organizations and semi‐voluntary or legal agencies; and (3) consideration of cultural differences.     

Diverging Trends in Female Old‐Age Mortality: The United States and the Netherlands versus France and Japan

In the most advanced countries, child mortality and adult mortality under age 65 years have fallen so low that further improvement in life expectancy relies almost completely on the decline of mortality at older ages. This phenomenon is particularly pronounced among women, who are far ahead of men in survival rates. Thus, to project the future of life expectancy, this study focuses on trends in female life expectancy at ages 65 and older. Four countries are selected for this analysis: the United States, Netherlands, France, and Japan. It is particularly interesting to understand why American and Dutch trends in female old‐age mortality have been diverging from those in France and Japan for two decades. It is shown here that most of the divergence derives from the fact that decline in cardiovascular mortality is more and more offset by increases in other causes of death in the United States and the Netherlands, while the other two countries are more successful in reducing mortality from all causes at increasingly older ages. This latter phenomenon could represent a new stage of the health transition.     

A basic program for the evaluation of the gamma functions

Some applications of the complete and incomplete gamma functions and the incomplete gamma integral to problems in agriculture are delineated and a BASIC computer program for their evaluation is briefly described.     

原子簇的合成方法、性质表征与结构

利用给电子有机和无机配位体的交换反应和金属卤化物与羰基金属阴离子的复分解反应,合成异核原子簇具有反应条件温和易于控制,收率较高的特点。本文描述Fe_3(CO)_9(C_2H_2)_3等11个原子簇的合成方法,配位状态与簇核的结构。     

High Sex Ratios at Birth in the Caucasus: Modern Technology to Satisfy Old Desires

During the 1990s, the sex ratio at birth increased considerably and simultaneously in the three independent Caucasian countries, Armenia, Azerbaijan, and Georgia. At the end of the first decade of the twenty‐first century, levels remain abnormally high in Armenia and Azerbaijan (above 114 male births per 100 female births) and show erratic trends in Georgia. Analyzing data from demographic surveys carried out around 2005, we confirm the persistence of high sex ratios in these three countries and document significant differences in fertility intentions and behavior according to the sex of the previous child or children that constitute evidence of the practice of sex‐selective abortion. These countries combine societal features and medical systems that make this phenomenon possible: son preference in a context of low fertility and the possibility of prenatal sex selection given easy access to ultrasound screening and induced abortion. Why high sex ratios are observed only in these three countries of the sub‐region remains, however, an open question.     

Attitudes towards using animals in research and teaching: opinions from a selected group of female secondary school students

Abstract

This research provides details about a group of young New Zealand women's awareness of, interest in and attitudes towards the use of animals in scientific research and teaching. These findings were compared to a similar survey of the New Zealand public. An adapted, anonymous questionnaire was used to gather data from 90 young women (14–15 years) from an urban secondary school. While nearly half expressed concern about animal use in research (43%), their awareness was not consistent with the reality of animal research in New Zealand, either in terms of its impact on animals or animal species used. They were unconcerned about the use of animals in teaching and associated such use with enhanced learning. Justification for the use of animals in research and teaching was shown to be complex and contextualized, with an instrumental qualifier being used to justify their opinions. Even though many students were unaware of the regulations surrounding animal use in research and teaching, they were mistrustful that these regulations were being followed by scientists. Instead, their trust was placed in the SPCA and in veterinarians.