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.     

Factors influencing Soay sheep survival

We present a survival analysis of Soay sheep mark recapture and recovery data. Unlike previous conditional analyses, it is not necessary to assume equality of recovery and recapture probabilities; instead these are estimated by maximum likelihood. Male and female sheep are treated separately, with the higher numbers and survival probabilities of the females resulting in a more complex model than that used for the males. In both cases, however, age and time aspects need to be included and there is a strong indication of a reduction in survival for sheep aged 7 years or more. Time variation in survival is related to the size of the population and selected weather variables, by using logistic regression. The size of the population significantly affects the survival probabilities of male and female lambs, and of female sheep aged 7 or more years. March rainfall and a measure of the North Atlantic oscillation are found to influence survival significantly for all age groups considered, for both males and females. Either of these weather variables can be used in a model. Several phenotypic and genotypic individual covariates are also fitted. The only covariate which is found to influence survival significantly is the type of horn of first-year female sheep. There is a substantial variation in the recovery probabilities over time, reflecting in part the increased effort when a population crash was expected. The goodness of fit of the model is checked by using graphical procedures.     

“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.     

Observational sketching as method

This paper explores the potential of observational sketching as a social science research tool, informed by our own recent experiments with observational sketching techniques and approaches. We first outline the historical roots of academic sketching and note a recent resurgence of interest in sketching in certain disciplines. We then introduce our own explorations in sketching as method, based on a year-long collaboration between an observational artist and a group of qualitative researchers with interests in creative methods. The paper outlines some of the lessons we learnt from our partnership, focusing on three themes: (i) ‘sketchiness’; (ii) ‘concentrated seeing’ and (iii) sketching as interaction. We conclude that observational sketching generates a refreshingly different form of visual data which has considerable potential to be used as a complement to other methods, including as a participatory method and as a useful tool for thinking.     

Conquering with capital: social,cultural, and economic capital’s role in combating socioeconomic disadvantage and contributing to educational attainment

While socioeconomic barriers to learning have been well-documented by education, sociology, and social policy scholars, further research is needed to understand how students with low-socioeconomic status excel in high-performing schools. The collection and analysis of 20 in-depth interviews with female college students from different racial and socioeconomic backgrounds provide rich insights into the stark differences between the educational practices of low and high-SES students. Building on Bourdieu’s conceptualization of how habitus and capital influence practices in the field of education exposes unique, strategic practices that low-SES students use to attain educational success within a system of reproduction and power. While entering a high-performing school is often perceived as a definitive step for accessing high-quality educational resources, my findings illustrate how it is actually an important intermediary step within a more complex process. Increasing educational opportunity and attainment for low-SES students requires improving their access to social, cultural, and economic capital through knowledgeable mentors who contribute to a habitus and portfolio of capital which enable practices to successfully navigate and challenge the educational system.     

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.