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.     

Society's search for a legal and ethical basis of physician-assisted suicide

A review of the way physician-assisted suicide (PAS) is being addressed in the United States reveals three models, each functioning out of distinctive concepts of autonomy: (1) litigation, which utilizes philosophical autonomy; (2) legislation, which utilizes political autonomy; and (3) act of conscience by a physician, which utilizes consumer autonomy. Each model raises a correspondingly distinct set of ethical questions and challenges centered around their point of reference-the judicial system, voters, or the doctor-patient relationship. In the end, however, efforts to resolve the challenge of PAS will falter if they do not go beyond these models of autonomy. Religious institutions offer a more constructive setting for facing the life and death decisionmaking of PAS. The challenge for religion is to address PAS in solidarity with sufferers, physicians, and the community, rather than retreating into iconoclastic dogmas.     

Differentiated leader–member exchange,justice climate,and performance: Main and interactive effects

Leaders form different quality leader–member exchange (LMX) relationships with their subordinates. This variable treatment termed LMX differentiation can have negative effects on individuals' behavior and attitudes. In this study, we examined the cross-level main effect of justice climate on task performance and the moderating role of justice climate on the relationship between LMX differentiation and task performance. We tested these two hypotheses using a field study of 90 subordinates nested under 27 supervisors. Procedural justice climate, not distributive justice climate, was found to positively influence subordinate task performance. Further, distributive justice climate, not procedural justice climate, was found to moderate the LMX differentiation–task performance relationship; such that the relationship was positive when distributive justice climate was high and negative when distributive justice climate was low. Findings and future directions are discussed.     

Non-Heterosexuality,Relationships, and Young Women’s Contraceptive Behavior

Non-heterosexual young women have a higher rate of unintended pregnancy than their heterosexual peers, but their fertility behaviors are understudied. We use longitudinal data from the Relationship Dynamics and Social Life study to investigate mechanisms contributing to non-heterosexual women’s higher pregnancy risk. These data include weekly reports of relationships, sex, and contraceptive use over 30 months. We compare the relationships and fertility behaviors of three groups: exclusively heterosexual (consistent heterosexual behavior, identity, and attraction); mostly heterosexual (heterosexual identity with same-sex behavior and/or same-sex attraction); and LGBTQ (any non-heterosexual identity). We find that mostly heterosexual and LGBTQ women behave differently from exclusively heterosexual women in ways likely to elevate their risk of unintended pregnancy: more distinct partners during the study period, more sexual intercourse with men, less frequent contraceptive use, less use of a dual method (condom plus hormonal method), and more gaps in contraceptive coverage. Mostly heterosexual women resemble LGBTQ women in their contraceptive behavior but have significantly more intercourse with men, which may increase their pregnancy risk relative to both LGBTQ and exclusively heterosexual women. We conclude by considering implications for LGBTQ health and the measurement of sexual minority populations.     

Brexit: Be Careful What You Wish For?

In this paper, I focus on the British future from Brexit. The institutional form this will take is not yet fixed. However, one can consider likely outcomes based on dominant economic frameworks. From this perspective, it seems unlikely that Brexit will address the actual grievances that resulted in Brexit. These transcend European Union membership.     

Testing the Vision: Preschool Settings as Places for Meeting,Bonding and Bridging

The OECD (2006 Starting Strong II: Early Childhood Education and Care. OECD Publishing: Paris) envisions early childhood education and care settings as meeting places for diverse social groups; places that build social capital. This vision was assessed in a comparison of three preschools types: full‐fee paying, subsidised‐fee and publicly funded. The social composition within each was examined and the connectedness of the children (n = 472) who attended compared. Publicly funded preschools had more socially diverse populations. The quantity of social connectedness did not differ but children in publicly funded preschools described higher quality social relationships. Not all preschool settings are socially diverse but, where they are, the quality of relationships is highest.     

Leadership of highly creative people in highly creative fields: A historiometric study of scientific leaders

In recent years there has been a marked increase in the study of the influence of leadership on creativity, and the effects of this relationship on organizational performance. While a number of explanations have been broached with regard to the positive effects of leadership on creativity, many of these studies propose different, and often contradictory, methods for leaders to achieve these positive effects on creativity within their organizations and work groups. Additionally, little work has been done examining the effects of leadership on highly creative people in fields requiring creativity. The purpose of this study is to examine two existing leadership theories with regard to their viability as models to explain creative performance of eminent scientists. Eminent scientists represent a population of leaders of highly creative individuals in a field that values the production of innovative ideas and products as a marker of performance. Ninety-three excerpts from the biographies of scientists were content coded for leader behaviors and performance criteria. The results of this analysis indicate that a model based on strategic planning and product championing may serve to explain the positive effects of leadership on creativity in a highly creative population.