Inference and Decision Making for 21st-Century Drug Development and Approval

ABSTRACT

The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get them and how they are used. The statistical framework for supporting decisions in regulated clinical development of new medicines has followed a traditional path of frequentist methodology. Trials using hypothesis tests of “no treatment effect” are done routinely, and the p-value < 0.05 is often the determinant of what constitutes a “successful” trial. Many drugs fail in clinical development, adding to the cost of new medicines, and some evidence points blame at the deficiencies of the frequentist paradigm. An unknown number effective medicines may have been abandoned because trials were declared “unsuccessful” due to a p-value exceeding 0.05. Recently, the Bayesian paradigm has shown utility in the clinical drug development process for its probability-based inference. We argue for a Bayesian approach that employs data from other trials as a “prior” for Phase 3 trials so that synthesized evidence across trials can be utilized to compute probability statements that are valuable for understanding the magnitude of treatment effect. Such a Bayesian paradigm provides a promising framework for improving statistical inference and regulatory decision making.     

Racial Differences in Abused Older African American Males, Caucasian Males, and their Abusers

This study examined racial differences between mistreated and abused older African American and Caucasian men. The racial and gender differences of their perpetrators were also examined. Data from a single elder abuse provider agency in the State of Illinois were analyzed. Differences with respect to physical abuse, emotional abuse, physical neglect, deprivation, confinement, and financial exploitation were examined, as were demographic characteristics and limitations of victims and abusers.     

EMPLOYER SPONSORED MEDICAL BENEFITS: The Influence of Occupational Characteristics and Gender

This research investigates gender differences in employer-sponsored medical fringe benefits: health insurance, dental insurance, sick leave, life insurance, and eye care coverage. Using data from a nationally representative sample of workers in the United States, human capital and structural theoretical approaches are drawn upon to explain the receipt of these benefits. The data suggest (a) men were more likely than women to receive each medical benefits from their employer; (b) occupational conditions largely account for the gender differences in coverage; (c) structural conditions of the occupation were more likely to predict the receipt of employer-sponsored medical benefits than were human capital attributes; (d) hazardous working conditions were not compensated for with medical benefits, with the exception of eye care coverage; and (e) gender did influence the relationship between several occupational conditions and benefit coverage.     

Coping with work stress: Psychological benefits of exercise

Although the health-enhancing effects of physical exercise have been well documented, less is known about how exercise benefits stressed employees psychologically. This article examines exercise as a coping response, and identifies changes in self-schemata (a person's underlying belief systems about him or herself) as the means by which exercise affects coping resources. In addition, by drawing on schema theory and the exercise literature, the active components of an exercise programme and the individuals who might enhance their ability to cope with stress through such a programme are identified.     

Racial differences in urban neighboring

Despite mixed expectations generated by existing theories and evidence, this analysis documents clear racial differences in urban neighboring behavior. Using data from a survey of Nashville, Tennessee, residents, we show that blacks interact with their neighbors more often than whites do, and in a greater variety of ways. The only noteworthy similarity between the two groups is the positive impact of neighboring on feelings of community affect. Overall, our results support the view that neighbor relations — like other kinds of informal participation — have helped blacks cope with constrained social opportunities and provided them with access to resources unavailable through formal institutional channels.Revised version of a paper presented at the annual meeting of the American Sociological Association, San Francisco, August 1989.     

Why the TVA Remains Unique: Interest Groups and the Defeat of New Deal River Planning*

Abstract Although scholars cite the Tennessee Valley Authority as one of President Franklin Roosevelt's major reform programs, the valley authority model did not replace the limited‐purpose water programs of the Bureau of Reclamation and the Army Corps of Engineers. State‐centered theorists hold that reformers are most likely to succeed during periods such as the New Deal era, when they are supported by a democratized polity and when they dominate Congress and the administration. This paper shows that in river policy, the strength of opposing interest groups also mattered. The TVA bill was passed in 1933 because reformers skillfully coordinated action at potential choke points and weakened the already disorganized opposing lobbyists. In 1936, however, after regrouping, opposing river lobbyists and legislators took advantage of the New Dealers' spending mood by expanding the Corps' flood control program. They also helped defeat further valley authorities, the most promising of the New Deal water policy reforms.     

Girls’ Jobs for the Boys? Men,Masculinity and Non‐Traditional Occupations

Occupational segregation by sex remains the most pervasive aspect of the labour market. In the past, most research on this topic has concentrated on explanations of women’s segregation into low paid and low status occupations, or investigations of women who have crossed gender boundaries into men’s jobs, and the potential impact on them and the occupations. In contrast, this article reports on a small‐scale, qualitative study of ten men who have crossed into what are generally defined as ‘women’s jobs’. In doing so, one of the impacts on them has been that they have experienced challenges to their masculine identity from various sources and in a variety of ways. The men’s reactions to these challenges, and their strategies for developing and accommodating their masculinity in light of these challenges, are illuminating. They either attempted to maintain a traditional masculinity by distancing themselves from female colleagues, and/or partially (re)constructed a different masculinity by identifying with their non‐traditional occupations. This they did as often as they deemed necessary as a response to different forms of challenge to their gender identities from both men and women. Finally, the article argues that these responses work to maintain the men as the dominant gender, even in these traditionally defined ‘women’s jobs’.