An assessment of the statistical methods used to analyse toxicology studies

The Statisticians in the Pharmaceutical Industry Toxicology Special Interest Group has collated and compared statistical analysis methods for a number of toxicology study types including general toxicology, genetic toxicology, safety pharmacology and carcinogenicity. In this paper, we present the study design, experimental units and analysis methods.     

Review of the statistical analysis of the dog telemetry study

In 2008, the PSI Toxicology Special Interest Group met to discuss the design and analysis of dog telemetry studies. The dog telemetry study is one component of the integrated cardiovascular assessment required by regulatory bodies. Although there are guidelines for these studies, little is said about the statistical analysis. With parameters of interest measured continually over time, in studies typically involving four dogs, the analysis is not straightforward. This has led to many different types of analysis being proposed in the literature, with many different methods applied within the pharmaceutical industry itself. This paper summarizes the PSI Toxicology group's discussions and recommendations around these issues.     

Changing society's DNA codes: Democracy and the global movement for community progress measures

This paper examines some critical issues and opportunities for democracy and public policy posed by the growth of the global progress measurement movement. From the democratic perspective, these include: citizen progress measurement as a form of democratic re‐engagement; the re‐examination of democracy and the development of new indicators to define and measure a ‘healthy’ democracy; and the demonstration of clear linkages between healthy regimes, and broader individual and societal wellbeing. In public policy, the global movement challenges two long dominant assumptions: the primacy of continuous economic growth as the key driver of wellbeing; and the ‘inevitability of progress‘. In their place, it offers a more holistic, integrated and nuanced model that recognises the interdependence of economic, social, cultural, environmental and democratic dimensions for genuine wellbeing, progress and sustainability. The paper reviews work in Australia over the past decade at both local community and national levels as examples of these trends, including the development of citizen‐engaged community planning and neighbourhood renewal schemes in which progress and wellbeing indicators play a central role; the development of state‐wide local progress measurement frameworks as part of a commitment to devolved planning and stronger local democracy; and the evolution of national progress measurement systems. The paper concludes with a proposal for a broad community engaged National Development Index (NDI) for Australia.     

An Inductive Analysis of Young Adults’ Conceptions of Femininity and Masculinity and Comparison to Established Gender Inventories

This study provides an analysis of the content of feminine and masculine characteristics/behaviors described in writing by 366 young women and 289 young men from the U.S. Emergent characteristics/behaviors were placed into domains. For both femininity and masculinity, the domains of “physical differences related to sex” and “emphasized physical differences” emerged. For masculinity, additional domains were: “activities and interests focused on the body,” “powerful or oriented toward power,” and “emotion-control or emotionally-limited.” For femininity, additional domains were “lacking power,” “orientation to other people,” and “emotional.” We then compared the characteristics/behaviors and domains we discovered to gender inventories that are commonly used in the contemporary period. The masculine domains focused on physical differences, activities, and interests that emerged from the present study are mostly absent from these masculinity inventories. The domains focused on power and restricted emotion are evident in these inventories, but these inventories do not cover all of the characteristics within our domains. The feminine domains that emerged from the present study are more often covered in these inventories, but some of the specific feminine characteristics we found are not evident in these inventories. Results are discussed in terms of gender role theory, gender inequality, and potential application for qualitative and quantitative inquiries into the construction of gender.     

Does welfare reform affect fertility? Evidence from the UK

This paper provides evidence on the effect of welfare reform on fertility, focusing on UK reforms in 1999 that increased per-child spending by 50% in real terms. We use a difference-in-differences approach, exploiting the fact that the reforms were targeted at low-income households. The reforms were likely to differentially affect the fertility of women in couples and single women because of the opportunity cost effects of the welfare-to-work element. We find no increase in births among single women, but evidence to support an increase in births (by around 15%) among coupled women.     

An evaluation of methods for testing hypotheses relating to two endpoints in a single clinical trial

The issues and dangers involved in testing multiple hypotheses are well recognised within the pharmaceutical industry. In reporting clinical trials, strenuous efforts are taken to avoid the inflation of type I error, with procedures such as the Bonferroni adjustment and its many elaborations and refinements being widely employed. Typically, such methods are conservative. They tend to be accurate if the multiple test statistics involved are mutually independent and achieve less than the type I error rate specified if these statistics are positively correlated. An alternative approach is to estimate the correlations between the test statistics and to perform a test that is conditional on those estimates being the true correlations. In this paper, we begin by assuming that test statistics are normally distributed and that their correlations are known. Under these circumstances, we explore several approaches to multiple testing, adapt them so that type I error is preserved exactly and then compare their powers over a range of true parameter values. For simplicity, the explorations are confined to the bivariate case. Having described the relative strengths and weaknesses of the approaches under study, we use simulation to assess the accuracy of the approximate theory developed when the correlations are estimated from the study data rather than being known in advance and when data are binary so that test statistics are only approximately normally distributed.     

Microcredit Self-Help Groups for Widowed and Abandoned Women in South India: Do They Help?

ABSTRACT

Results are presented from a study on a microcredit program with self-help groups implemented for widowed and abandoned women in Tamil Nadu shortly after the Indian Ocean Tsunami. Data were collected from 109 participants measuring the women's investment patterns, loan amounts, demographics, and overall well-being (psychological, economic, communal, and familial). Results indicate that loan amounts and investment patterns were not significantly related to the women's well-being. Length of group participation and having children were negatively related to the women's well-being. These findings are discussed in relation to social and cultural contexts. Suggestions for programs for this population of vulnerable women and other marginalized groups are proposed.     

The social inclusion policy agenda in Australia: a case of old wine,new bottles?

The election of an Australian Labor Government in Australia in 2007 saw ‘social inclusion’ emerge as the official and overarching social policy agenda. Being ‘included’ was subsequently defined by the ALP Government as being able to ‘have the resources, opportunities and capabilities needed to learn, work, engage and have a voice‘. Various researchers in Australia demonstrated an interest in social inclusion, as it enabled them to construct a multi‐dimensional framework for measuring disadvantage. This research program resulted in various forms of statistical modelling based on some agreement about what it means to be included in society. The multi‐dimensional approach taken by academic researchers, however, did not necessarily translate to a new model of social policy development or implementation. We argue that, similar to the experience of the UK, Australia's social inclusion policy agenda was for the most part narrowly and individually defined by politicians and policy makers, particularly in terms of equating being employed with being included. We conclude with discussion about the need to strengthen the social inclusion framework by adopting an understanding of social inequality and social justice that is more relational and less categorical.     

Flexibility, Hierarchy, Markets

The conclusion that organizations need to become more strategically flexible as a response to increasing environmental dynamism and uncertainty has been an important feature of recent contingency theories of organization design. In this literature organizations have been analysed from the perspective of the development of networks of organizations concentrating on their core competencies and contracting among themselves on a stable long-term basis. This model of inter-firm relationships provides an alternative mode of organizational structuring to that arising from vertical integration, which, by contrast, is seen as fostering strategic inflexibility. In the literature on corporate restructuring and changes in ownership form arising from the markets and hierarchies perspective, we see a similar emphasis on the dysfunctional consequences of large-scale bureaucratic organization. Changes in ownership form are seen as a major means of providing more effective managerial control. In this paper we argue that linking the literature on flexibility emanating from contingency theories of organizational design and the markets and hierarchies perspective provides important new insights into current and emerging forms of organization.