Suchergebnisse

One intriguing aspect of western colonisation at the turn of the nineteenth century in the South Pacific is the development within the US of a distinctly 'Old World' imperial imaginary. This happened after the Spanish-American War of 1898 through which the US acquired extra-territorial possessions in the Caribbean and the Pacific-the inspiration for Rudyard Kipling's poem 'The White Man's Burden'. This essay explores this transition from one phase of colonialism to another through the work of two prominent authors who lived and worked in the region during this tumultuous period: Robert Louis Stevenson and Jack London.

In 1879, an impoverished Stevenson travelled from Scotland to California in conditions almost identical to those of working-class and poverty-stricken emigrants. His account, The Amateur Emigrant, shocked the class sensitivities of his family and friends, and was not published in full in his lifetime. The experience had a profound effect on Stevenson's personal sensibilities; his consciousness of his ambivalent position as a middle-class writer in the midst of his working-class contemporaries renders The Amateur Emigrant a remarkable revelation of the intermingled complexities of class, race and gender in late Victorian England.

The recent benefit–risk framework (BRF) developed by the Food and Drug Administration (FDA) is intended to improve the clarity and consistency in communicating the reasoning behind the FDA's decisions, acting as an important advancement in US drug regulation. In the PDUFA VI implementation plan, the FDA states that it will continue to explore more structured or quantitative decision analysis approaches; however, it restricts their use within the current BRF that is purely qualitative. By contrast, European regulators and researchers have been long exploring the use of quantitative decision analysis approaches for evaluating drug benefit–risk balance. In this paper, we show how quantitative modelling, backed by decision theory, could complement and extend the FDA's BRF to better support the appraisal of evidence and improve decision outcomes. After providing relevant scientific definitions for benefit–risk assessment and describing the FDA and European Medicines Agency (EMA) frameworks, we explain the components of and differences between qualitative and quantitative approaches. We present lessons learned from the EMA experience with the use of quantitative modelling and we provide evidence of its benefits, illustrated by a real case study that helped to resolve differences of judgements among EMA regulators.

The recent benefit-risk framework (BRF) developed by the Food and Drug Administration (FDA) is intended to improve the clarity and consistency in communicating the reasoning behind the FDA's decisions, acting as an important advancement in US drug regulation. In the PDUFA VI implementation plan, the FDA states that it will continue to explore more structured or quantitative decision analysis approaches; however, it restricts their use within the current BRF that is purely qualitative. By contrast, European regulators and researchers have been long exploring the use of quantitative decision analysis approaches for evaluating drug benefit-risk balance. In this paper, we show how quantitative modelling, backed by decision theory, could complement and extend the FDA's BRF to better support the appraisal of evidence and improve decision outcomes. After providing relevant scientific definitions for benefit-risk assessment and describing the FDA and European Medicines Agency (EMA) frameworks, we explain the components of and differences between qualitative and quantitative approaches. We present lessons learned from the EMA experience with the use of quantitative modelling and we provide evidence of its benefits, illustrated by a real case study that helped to resolve differences of judgements among EMA regulators.