D-efficient window experimental designs

In the paper we present a new method of calculating sampling intervals, so-called windows, allowing an experimenter some flexibility in timing the sample collection, while a minimum required design efficiency for parameter estimation is assured. The method is based on the Equivalence Theorem for D-optimality what makes the length of each window related to the parameter sensitivities. An example of calculating the windows in a pharmacokinetic study is presented. Some other methods of calculating efficient sampling windows are briefly discussed.     

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.     

Organizational Compatibility and Workplace Drug Testing: Modeling the Adoption of Innovative Social Control Practices

Few researchers have examined organizational variation in the adoption of workplace drug testing, but innovation theory suggests that adoption is more likely when it is compatible with an organization's values, previously introduced ideas, and needs. Using data from the 1997 National Employee Survey, this research models the effects of organizational compatibility, industry, and establishment size on the adoption of drug testing. The data reveal that compatibility, as measured by an organization's rules orientation, presence of an employee assistance program, and mechanization, is associated with the adoption of drug testing. As predicted, the adoption of drug testing varies across industries and by establishment size.     

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 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.