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.     

Acing the 'chemistry' test

With the right boss, you can go far and learn much. The wrong boss could actually slow or even stall your executive career. When you interview for a job, you're also interviewing for a boss--and it's in your own interest to try to find the individual who is the best possible fit with your own management style. This is a matching process--not quite a courtship, but with some of the same characteristics. What can you do to ensure a good match with your new boss? (1) Do your homework; (2) Make your interview a dialog; (3) Use subtle strategies, too, such as watching for body language; (4) Ask the employer for references; and (5) Know yourself.     

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.     

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.     

Sampling schemes for price index construction: a performance comparison across the classification of individual consumption by purpose food groups

Five sampling schemes (SS) for price index construction – one cut-off sampling technique and four probability-proportional-to-size (pps) methods – are evaluated by comparing their performance on a homescan market research data set across 21 months for each of the 13 classification of individual consumption by purpose (COICOP) food groups. Classifications are derived for each of the food groups and the population index value is used as a reference to derive performance error measures, such as root mean squared error, bias and standard deviation for each food type. Repeated samples are taken for each of the pps schemes and the resulting performance error measures analysed using regression of three of the pps schemes to assess the overall effect of SS and COICOP group whilst controlling for sample size, month and population index value. Cut-off sampling appears to perform less well than pps methods and multistage pps seems to have no advantage over its single-stage counterpart. The jackknife resampling technique is also explored as a means of estimating the standard error of the index and compared with the actual results from repeated sampling.     

Researching social work: Doctoral work in the UK

This paper discusses some current issues in relation to doctoral studies in social work in the UK. It draws on recent research and other sources to illustrate that our knowledge about the scope and scale of such doctoral work is limited. However, developments within the discipline and the wider policy and institutional context of professional education suggest that research (in general) has an increasing profile. This trend, together with debates about focus and research approaches in social work, has implications for the possible extension of opportunities for doctoral studies. It is further suggested that 'professional doctorate' programmes or 'PhD by publication' routes may be more suited to the needs of doctoral students in social work, given different career paths relative to students in some other disciplines.