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.     

Why sociology does not need to be saved: Analytic reflections on public sociologies

After reviewing the debate about public sociologies in the American Sociological Association over the past few years, we offer a response to calls for “saving sociology” from the Burawoy approach as well as an analytic critique of the former ASA president's “For Public Sociology” address. While being sympathetic to the basic idea of public sociologies, we argue that the “reflexive” and “critical” categories of sociology, as Burawoy has conceptualized them, are too ambiguous and value-laden to allow for empirical investigation of the different major orientations of sociological research and the ways the discipline can address non-academic audiences. Debates about the future of sociology should be undertaken with empirical evidence, and we need a theoretical approach that can allow us to compare both disciplines and nations as well as taking into account the institutional context of the universities in which we operate. Research into the conditions under which professional, critical, policy, and public sociologies could work together for the larger disciplinary and societal good is called for instead of overheated rhetoric both for and against public sociologies.     

Secondary analysis of dangerousness among death sentenced capital murderers

The theory of incapacitation involves reducing an offender's ability or capacity to commit further crimes. Capital punishment accomplishes this goal. An executed murderer never murders again. However, we do not execute all murderers, only capital murderers. This policy produces several research questions. Do capital murderers present a special risk to society? Are capital murderers more likely to murder or commit other violent crimes again than other murderers or the average citizen? To answer these questions, many states require a prediction of future dangerousness of a newly convicted murderer. To what extent has the judgment of future dangerousness matched actuarial data of subsequent murders and serious crimes? Using a secondary analysis, this investigation attempted to assemble available data of postconviction dangerousness of death sentenced capital murderers to create a more comprehensive actuarial account of subsequent dangerousness and to present the data in a common format used by the Federal Bureau of Investigation and the Bureau of Justice Statistics. Across 14 studies identified with relevant data, there were 13 instances of subsequent murder and 462 serious crime or prison rule violations.     

Buying a Dream: Alternative Models of Demand for Lotto

Existing lotto demand models utilize effective price, computed as the face value of a ticket minus the expected value of prize money per ticket, as their primary explanatory variable. By contrast, this article proposes a key role for consumption benefit or "fun" in the demand for gambling in general and lotto demand in particular. It develops an alternative model of lotto demand that focuses on the maximum possible prize. When this is tested against the traditional model using data from the U.K. National Lottery, we find that jackpot considerations exert an influence over and above that of variations in effective price.     

Awkward Customers? Parents and Provision for Special Educational Needs

This article selectively reports on a small-scale qualitative exploration of the experiences of families who had undergone recent conflict with special educational needs (SEN) professionals. The data were collected over the spring and summer terms of 2001 from 10 families in two local education authorities (LEAs) in the English midlands. The research aimed to examine the parents' perspectives on points of conflict or dissatisfaction between themselves and education professionals. It was concerned with the parents' points of view regarding their pursuit of desired outcomes for their children and the factors that helped or hindered their endeavours. The project found that the parents' negotiation of the SEN system was held by them to be exceptionally difficult and stressful compared to other troubling issues in their lives. The research suggests that dissatisfactions with SEN provision have important implications for the management of LEA Parent partnership Schemes (PPS) in ameliorating the differences between parental aspirations and governmental ambition.     

‘It's their word against mine’: young people's attitudes to the police complaints procedure in Northern Ireland

One of the central aims of the police reform process in Northern Ireland has been to increase the legitimacy of the policing structures and police officers amongst those who are served and policed by the Police Service of Northern Ireland (PSNI). To meet this aim, structures have been created to ensure that the PSNI is accountable to all sections of the community for its strategy and performance, and in monitoring the attitudes and behaviour of its officers. To that end, the Office of the Police Ombudsman for Northern Ireland (PONI), the Northern Ireland Policing Board and 26 District Policing Partnerships have been created. This paper aims to break ground by looking in some detail at young people's attitudes to and experiences of the workings of one of those new bodies, the Police Ombudsman, and to explore issues related to young people's willingness to engage with the PONI.     

Gender disparity in the C-suite: Do male and female CEOs differ in how they reached the top?

Through a comparison of the life and career trajectories of thirty male and thirty female CEOs of large organizations, this study offers insights into the genesis of gender disparity in corporate leadership positions, discusses the implications for leadership development, and puts forward a model explaining the disparity in CEO roles. We found gendered patterns in the accumulation of career relevant experiences stretching back to birth into working lives that created significant and cumulative limitations upon the ability of women to access CEO roles and the types of CEO appointments available to them. Limited access to career relevant experiences in childhood, adolescence and in organizations lead to on-going limitations in capital accumulation throughout women's careers. Implications of our findings for both theory and practice are discussed.