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.     

General Job Satisfaction From a Developmental Perspective: Exploring Choice—Job Matches at Two Career Stages

The authors explored predictions of general job satisfaction at early and middle adulthood and uncovered several findings about developmental processes associated with job satisfaction. Tests of life‐span career theory propositions revealed that neither choice‐job congruence nor gender added significantly to predictions of job satisfaction at 2 career stages. Earlier occupational choice and current job added to predictions of midcareer (modal age 43 years) job satisfaction, especially for men. The predictability of job satisfaction is apparently influenced by the career stage when satisfaction is appraised.     

Neighborhood Structure,Social Organization,and Number of Short‐Term Sexual Partnerships

We examine the relationship between neighborhood structural characteristics, social organization, and the sexual partnering practices of adults. Analyses of 1990 census and 1995–1997 survey‐based data on Chicago neighborhoods and adult sexual activity reveal for men a number of neighborhood influences on sexual partnering practices. First, residential stability is negatively associated with having a short‐term sexual partner in the last year. Second, neighborhood social ties are positively associated with short‐term sexual partnering in neighborhoods with low levels of collective efficacy—the combination of cohesion and shared expectations for beneficial action among neighbors—but this effect is substantially reduced as collective efficacy increases. Moreover, neighborhood collective efficacy and social ties mediate the effect of residential stability on sexual partnering practices. Neighborhood characteristics were not associated with short‐term sexual partnering for women.     

'The Tribunal was the most stressful thing: more stressful than my son's diagnosis or behaviour': the experiences of families who go to the Special Educational Needs and Disability Tribunal (SENDisT)

It is more than 10 years since the Special Educational Needs Tribunal was established in 1994 as an independent panel which arbitrates in disputes between parents of children with the label special educational needs and Local Education Authorities (LEAs) in England. In 2002 the Tribunal began hearing claims for disability discrimination and was re-named the Special Educational Needs and Disability Tribunal (SENDisT). Since 1994 over 20,000 appeals have been registered. This article, which forms part of my ongoing Ph.D. thesis 'Parents as advocates: the experience of parents who register an appeal with SENDisT', offers an analysis of parents' Tribunal stories. Here, the key question is what affect the process of going to SENDisT has on the social, emotional and financial well-being of the family. Through a process of narrative inquiry the aim is to foreground parents' unheard stories and to reveal their 'hidden' experiences.     

Partner Choice and the Differential Retreat From Marriage

The contemporary retreat from marriage in the United States has had a differential impact across socioeconomic and racial groups. Here, 1990 marriage rates and propensities for Virginia, North Carolina, and Wisconsin are analyzed regarding (a) the likelihood that persons in different groups ever marry and (b) patterns of partner choice with respect to race and educational level. Marriage remains strong in most race‐education groups but is substantially lower among Blacks and among those with less than 12 years of education. Patterns of partner choice have shifted to show greater symmetry between the educational levels of brides and grooms. Changes have been modest with regard to the level and pattern of interracial (Black‐White) marriage. Marriage is increasingly a union of equals, but a union chosen more by Whites than by Blacks and more by the well educated than by the poorly educated.     

Modelling map positional error to infer true feature location

The authors consider the issue of map positional error, or the difference between location as represented in a spatial database (i.e., a map) and the corresponding unobservable true location. They propose a fully model‐based approach that incorporates aspects of the map registration process commonly performed by users of geographic informations systems, including rubber‐sheeting. They explain how estimates of positional error can be obtained, hence estimates of true location. They show that with multiple maps of varying accuracy along with ground truthing data, suitable model averaging offers a strategy for using all of the maps to learn about true location.     

The Division of Household Labor in Germany and Israel

We compare the patterns of household division of labor in Germany and Israel—two countries that share key elements of the corporatist welfare regime but differ in their gender regimes—and evaluate several hypotheses using data from the 2002 International Social Survey Program. Although time constraints and relative resources affect the division of household labor and women’s housework in both societies, we find that in Germany the gender order of household labor is more rigid, whereas in Israel the spouses’ linked labor market status exerts distinctive effects. We also find significant relationships between gender ideology and the division of household labor. We discuss the theoretical advantages of approaching the comparative study of gender inequality from the vantage point of family and gender regimes.     

The vegetarian option: varieties, conversions, motives and careers

This paper reports the findings of a qualitative study of the dietary beliefs and practices of a ‘snowball sample’ of seventy-six vegetarians and vegans. The dynamics of the process of conversion are examined, along with respondents'accounts of their motives and of the impact of their dietary stance upon their relationships with kin, friends and colleagues. The study's findings, which appear to indicate the central importance of ethical considerations for this particular response group, are set in the context of broader debates concerning the sociological dimensions of the selection or avoidance of specific food items.