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.     

Generating recognition,acceptance and social inclusion in marginalised youth populations: the potential of sports-based interventions

In recent years sport-based interventions have been implemented as a mechanism via which to target marginalised youth in relation to the development of social inclusion. Much of the political rhetoric surrounding social inclusion programmes highlights engagement with education, employment, or training, as key metrics. This has led some scholars to observe that conceptualising social inclusion in this way can act to further marginalise young people who fail to engage with these metrics. In contrast, this paper seeks to employ an alternative understanding of social inclusion, which uses the concepts of recognition and acceptance, to infer how participation in sports-based programmes may enable marginalised youth to meet mainstream societal expectations and aid with social assimilation. Drawing upon findings from two small-scale studies of sport-based interventions located in three UK cities, this paper places participant accounts at the centre of the analysis to explore broader notions of pro-social development in relation to recognition and interpersonal acceptance. The paper concludes by suggesting that within contexts in which young people are able to generate strong interpersonal relationships with key personnel (such as coaches), and which are built upon trust, recognition and developing self-worth, there is clear potential for sport-based programmes to incubate social assimilation.     

100 key research questions for the post‐2015 development agenda

The Sustainable Development Goals (SDGs) herald a new phase for international development. This article presents the results of a consultative exercise to collaboratively identify 100 research questions of critical importance for the post‐2015 international development agenda. The final shortlist is grouped into nine thematic areas and was selected by 21 representatives of international and non‐governmental organisations and consultancies, and 14 academics with diverse disciplinary expertise from an initial pool of 704 questions submitted by 110 organisations based in 34 countries. The shortlist includes questions addressing long‐standing problems, new challenges and broader issues related to development policies, practices and institutions. Collectively, these questions are relevant for future development‐related research priorities of governmental and non‐governmental organisations worldwide and could act as focal points for transdisciplinary research collaborations.     

Trajectories of Unintended Fertility

Having an unintended birth is strongly associated with the likelihood of having later unintended births. We use detailed longitudinal data from the Add Health Study (N = 8300) to investigate whether a host of measured sociodemographic, personality, and psychosocial characteristics select women into this “trajectory” of unintended childbearing. While some measured characteristics and aspects of the unfolding life course are related to unintended childbearing, explicitly modeling these effects does not greatly attenuate the association of an unintended birth with a subsequent one. Next, we statistically control for unmeasured time-invariant covariates that affect all birth intervals, and again find that the association of an unintended birth with subsequent ones remains strong. This persistent, strong association may be the direct result of experiencing an earlier unintended birth. We propose several mechanisms that might explain this strong association.     

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.     

“Thank You for Including Us!” – Introducing a Community‐Based Collaborative Approach to Translating Clinic Materials

When working with clients in another language, having culturally relevant and properly translated clinic materials is vital to effective clinical practice. Not having them presents a barrier for bilingual therapists and their clients. This paper reviews common translation methods and introduces a multi‐level, community‐based approach for translating clinic materials for non‐English speaking clients. Informed by decolonizing practices, this five‐tier method includes members from the target community as cultural brokers to verify the accuracy and nuances of language for their cultural group, as well as a constant comparative method to ensure methodological rigor in the process of inclusion. We present community member's feedback and recommendations, as well as discuss advantages and challenges of using this collaborative culturally responsive translation method.