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.     

Child Care “Packaging” Among TANF Recipients: Implications for Social Work

This article reports the results of a study that examined the ways in which current and recent TANF recipients assembled or “packaged” their child care arrangements among formal and informal providers. The findings are drawn from in-person, in-depth interviews with current and former welfare recipients. The study found that most of the respondents used multiple providers within the category of informal child care for reasons including availability, the use of a network of social acquaintances as a problem-solving resource, the need to accommodate irregular work hours, and personal trauma that contributed to a distrust of strangers in formal settings. The findings can affect the efficacy of practice with TANF recipients by contributing to social workers’ understanding of the context of decision-making regarding child care.