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.     

Enterprising? Disabled? The status and potential for disabled people’s microenterprise in South Korea

This article explores the position, potential and scope for self-employment and microenterprise for disabled South Koreans. The chronic barriers experienced in disabled people gaining paid work suggest that self-employment and enterprise might offer a good alternative to paid work. The self-determined nature of running a microenterprise has been shown to connect with disabled people who may not conform to standardised notions of body and brain that underpin many mainstream work contexts. Despite this promise, several barriers continue to beset disabled people’s access to micro-enterprise activity; barriers ranging from Confucian precepts, to employment protections that are geared largely towards paid employment and to the lack of training, finance and business support for disabled people starting up and sustaining microenterprise in Korea. The extension of legal protections, meaningful start-up subsidies, better business support and bridges between paid work and microenterprise are all seen as important policy correctives that would better support disabled people.     

Marxist sociology and humanist sociology: Diversity, intersections, and convergence

Marxist sociology is at the intersection of Marxism and sociology; while humanist sociology is at the intersection of humanist thought and sociology. Both see sociological theory as a living, evolving activity, and both take a critical stance toward the workings of capitalism. The main difference between them is that Marxist sociology is a body of thought tied to a movement, whereas humanist sociology is a movement tied to a body of thought. Professor of Sociology, Purdue University Calumet. He is past chair of the Section on Marxist Sociology, has been a member of the AHS for twenty years, and is co-author of Crisis and Change: Basic Questions of Marxist Sociology.     

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.     

Review Essay: On the Trail of Tribal Sociology

Sociological Forum -     

Charismatic leadership in business organizations: Some neglected issues

The article reviews some of the recent literature on charismatic leadership and notes that there has been a tendency for research and theorizing to emphasize a number of issues examined by Weber to the relative exclusion of others. Those areas that have been focused upon, have tended to reflect the “applied” emphasis in much research in the field of leadership in organizations. The article takes two areas that were central to Weber's work—routinization of charisma and loss of charisma—to demonstrate that these topics can illuminate and add to our understanding of the operation of charismatic leadership in business and other formal organizations.     

ON THE MACROFOUNDATIONS OF MICROSOCIOLOGY:

Just as Collins (1981) demonstrates that microsociological presuppositions elucidate macrosociology, the reverse holds as well. Fundamental axioms are the existence of (1) a set of constraints that channel individual action and expectations and (2) obdurate, exterior realities of supraindividual entities. Expanding on these presuppositions this article proposes a set of issues that collectively help provide a macrosociological basis for interpretive microsociology: the physical limits of the built environment, temporal and spatial effects, institutional linkages, the obdurate reality of tradition, and beliefs in organizational primacy. These underline the often unrecognized centrality and legitimacy of macrosociological analysis for the development of microsociology.