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.     

Punishment and pleasure: women, food and the imprisoned body1

Food assumes enormous importance in prison: for many prisoners it conditions their life in custody and, in many respects, is symbolic of the prison experience. This article explores the complex relationship between gender, food and imprisonment through an analysis of data obtained from in‐depth interviews and group discussions conducted in three women's prisons in England. The findings indicate that, in prison, where control is taken away as the prisoner and her body become the objects of external forces, food is experienced not only as part of the disciplinary machinery, but also as a powerful source of pleasure, resistance and rebellion. The implications of such findings for health promotion in the prison context are discussed. Here, the pleasures and consolations of food may well constitute a redefinition of what it is to be healthy in this context, one that challenges the dominant meaning constructed in current health promotional discourse.     

The Persistent Problem of Colorism: Skin Tone, Status, and Inequality

Colorism is a persistent problem for people of color in the USA. Colorism, or skin color stratification, is a process that privileges light-skinned people of color over dark in areas such as income, education, housing, and the marriage market. This essay describes the experiences of African Americans, Latinos, and Asian Americans with regard to skin color. Research demonstrates that light-skinned people have clear advantages in these areas, even when controlling for other background variables. However, dark-skinned people of color are typically regarded as more ethnically authentic or legitimate than light-skinned people. Colorism is directly related to the larger system of racism in the USA and around the world. The color complex is also exported around the globe, in part through US media images, and helps to sustain the multibillion-dollar skin bleaching and cosmetic surgery industries.     

Police Reforms in Child Abuse Investigation: Their Success and Limitations in the Struggle to Uphold Children's Rights

SUMMARY. The past decade has shown increased awareness, concern and understanding about the extent of child abuse, particularly sexual abuse, and the caring agencies response to listen to and to support the young victims. This article looks at the response of the police service over that decade to meet such demands and to work jointly and responsively with social services to further the welfare and protection of children. It also examines the constraints and limitations of the police and social services when they attempt to uphold the rights of child victims and to gain redress through the criminal justice system