Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials

Background Despite the promising benefits of adaptive designs (ADs), their routine use, especially in confirmatory trials, is lagging behind the prominence given to them in the statistical literature. Much of the previous research to understand barriers and potential facilitators to the use of ADs has been driven from a pharmaceutical drug development perspective, with little focus on trials in the public sector. In this paper, we explore key stakeholders’ experiences, perceptions and views on barriers and facilitators to the use of ADs in publicly funded confirmatory trials. Methods Semi-structured, in-depth interviews of key stakeholders in clinical trials research (CTU directors, funding board and panel members, statisticians, regulators, chief investigators, data monitoring committee members and health economists) were conducted through telephone or face-to-face sessions, predominantly in the UK. We purposively selected participants sequentially to optimise maximum variation in views and experiences. We employed the framework approach to analyse the qualitative data. Results We interviewed 27 participants. We found some of the perceived barriers to be: lack of knowledge and experience coupled with paucity of case studies, lack of applied training, degree of reluctance to use ADs, lack of bridge funding and time to support design work, lack of statistical expertise, some anxiety about the impact of early trial stopping on researchers’ employment contracts, lack of understanding of acceptable scope of ADs and when ADs are appropriate, and statistical and practical complexities. Reluctance to use ADs seemed to be influenced by: therapeutic area, unfamiliarity, concerns about their robustness in decision-making and acceptability of findings to change practice, perceived complexities and proposed type of AD, among others. Conclusions There are still considerable multifaceted, individual and organisational obstacles to be addressed to improve uptake, and successful implementation of ADs when appropriate. Nevertheless, inferred positive change in attitudes and receptiveness towards the appropriate use of ADs by public funders are supportive and are a stepping stone for the future utilisation of ADs by researchers.

Il realismo di un nuovissimo medio evo: Boccaccio in the age of neorealism

After the war Italian artists and intellectuals saw a significant and necessary confluence between their political desire to create a "new." Italy and their cultural ambition to re-invigorate the study of medieval Italy. This tendency is particularly evident, I argue, in the post-war scholarly and critical focus on Boccaccio, and especially Boccaccio’s Decameron. Not only within the academy but also in the popular press, Boccaccio was granted pride of place in the canon, venerated as the pioneer of socially conscious vernacular literary realism, the archetype for the pursuit of artistic truth in the face of social upheaval. As a result, I wish to suggest, Italian neorealism, which rose to prominence in the first years after the Second World War, was in a significant sense imbued with and realised through a profound engagement with the work of Boccaccio. In turn, the cultural currents affiliated with neorealism influenced Boccaccio studies, whose operative notions of medieval «realism» were to a perhaps surprising degree stimulated by approaches to the neo-realist poetics at work in the Italian films, novels, and criticism of the 1940s and ’50s. Situating the critical discourse surrounding Boccaccio within the post-war Italian context can therefore serve to shed unexpected light on both the cultural affirmation of neorealism and the disciplinary configuration of Italian medieval studies.

The new Hollywood, 1981–1999: special/visual effects

The emergence and development of digital imaging technologies and their impact on mainstream filmmaking is perhaps the most familiar special effects narrative associated with the years 1981-1999. This is in part because some of the questions raised by the rise of the digital still concern us now, but also because key milestone films showcasing advancements in digital imaging technologies appear in this period, including Tron (1982) and its computer generated image elements, the digital morphing in The Abyss (1989) and Terminator 2: Judgment Day (1991), computer animation in Jurassic Park (1993) and Toy Story (1995), digital extras in Titanic (1997), and ‘bullet time’ in The Matrix (1999). As a result it is tempting to characterize 1981-1999 as a ‘transitional period’ in which digital imaging processes grow in prominence and technical sophistication, and what we might call ‘analogue’ special effects processes correspondingly become less common. But such a narrative risks eliding the other practices that also shape effects sequences in this period. Indeed, the 1980s and 1990s are striking for the diverse range of effects practices in evidence in both big budget films and lower budget productions, and for the extent to which analogue practices persist independently of or alongside digital effects work in a range of production and genre contexts. The chapter seeks to document and celebrate this diversity and plurality, this sustaining of earlier traditions of effects practice alongside newer processes, this experimentation with materials and technologies old and new in the service of aesthetic aspirations alongside budgetary and technical constraints. The common characterization of the period as a series of rapid transformations in production workflows, practices and technologies will be interrogated in relation to the persistence of certain key figures as Douglas Trumbull, John Dykstra, and James Cameron, but also through a consideration of the contexts for and influences on creative decision-making. Comparative analyses of the processes used to articulate bodies, space and scale in effects sequences drawn from different generic sites of special effects work, including science fiction, fantasy, and horror, will provide a further frame for the chapter’s mapping of the commonalities and specificities, continuities and variations in effects practices across the period. In the process, the chapter seeks to reclaim analogue processes’ contribution both to moments of explicit spectacle, and to diegetic verisimilitude, in the decades most often associated with the digital’s ‘arrival’.

Family, locality and nationality: vernacular adaptations of the Expugnatio Hibernica from late medieval Ireland

This paper examines two late medieval abridgements of Gerald of Wales’ Expugnatio Hibernica, one in Hiberno-English and one in Irish. The manuscripts in which these adaptations survive all date from the late fifteenth century and appear to bear witness to a sudden and pronounced interest in Gerald’s text. Drawing on evidence from the extant manuscripts, this paper explores the readerships of, and the nature of their interest in, these adaptations. A key conclusion is that the Expugnatio, which gives prominence to Gerald's own relatives, the Fitzgeralds, was valued as a family history by the Fitzgerald Earls of Kildare and their allies. The Earls were at the height of their power in the period in which these manuscripts were produced. Examination of this neglected evidence of the adaptation and readership of the Expugnatio in late medieval Ireland suggests that, for some medieval readers at least, the primary identities Gerald’s text expressed were familial and local rather than colonial or national.

The evolution and heterogeneity of outward foreign direct investment from Latin America

The PhD dissertation investigates the rise of emerging country multinationals (EMNEs), a phenomenon that has opened up a series of research themes and debates. The main debate in this field is the extent to which the theories/frameworks on foreign direct investment (FDI), which have been developed from investigations on multinationals from developed countries, is relevant in explaining outward FDI from EMNEs. This debate is sparked by research suggesting that EMNEs supposedly do not hold the characteristics that are seen as a prerequisite to engaging in FDI. The underlying theme in this PhD is that the field should move away from a one size fit all categorisation of EMNEs, and explore the heterogeneity within EMNEs. Collecting data through various databases, archival articles and annual reports, there was an examination of the internationalisation process of 136 Latin American Multinationals (LAMNEs). The research explores the differences in internationalisation trajectories and global strategies and classifies firms into one of four categories. The four categories that LAMNEs fall into are: Natural-Resource Vertical Integrator, which are firms that are in resource seeking sectors; Accelerated Global, which depict firms that have become global over a very short period of time; Traditional Global, which are EMNEs that have internationalised at the same pace as developed country MNEs and Local Optimisers that only acquire or internationalise to developing countries. The analysis also looks at which decade LAMNEs engaged in FDI, to see if LAMNEs that internationalised during the 1970s and 1980s, during a time when Latin America had a closed economy, was different to LAMNEs that internationalised during the Washington consensus era of the 1990s or to firms that have only just internationalised within the last decade. The findings show that LAMNEs that internationalised before 1990 were more likely to adopt Local Optimiser strategies. However, more LAMNEs that started to internationalise during the 1990s started to adopt Traditional Global strategies, although Local Optimisers were the most prominent strategy. From 2002, there was more prominence of Accelerated Global strategies and a lot more heterogeneity among LAMNEs. Natural-Resource Vertical Integrator LAMNEs, tended to start to internationalisation process during the 1970s/1980s. Despite the rise of EMNEs, and by extension LAMNEs opting to use cross border merger and acquisitions (M&A), there is little research on whether this entry mode has been successful. Contrary to the argument that EMNEs are “internationalising successfully” through this strategy, the findings show that these firms are highly geared and are running less efficiently against their Western competitors. In comparison, LAMNEs internationalising through a more gradual approach, are outperforming their Western competitors on efficiency and are not highly geared- i.e. do not hold a lot of debt. The conclusion of the thesis is the emphasis of moving away from evaluating firms from their country or region of origin, but rather through the global strategy they are using. This will give a more a robust firm level of analysis, and help develop the understanding of EMNEs and international business theory.

Doing well by talking good? A topic modelling-assisted discourse study of corporate social responsibility

Using the novel technique of topic modelling, this paper examines thematic patterns and their changes over time in a large corpus of corporate social responsibility (CSR) reports produced in the oil sector. Whereas previous research on corporate communications has been small-scale or interested in selected lexical aspects and thematic categories identified ex ante, our approach allows for thematic patterns to emerge from the data. The analysis reveals a number of major trends and topic shifts pointing to changing practices of CSR. Nowadays ‘people’, ‘communities’ and ‘rights’ seem to be given more prominence, whereas ‘environmental protection’ appears to be less relevant. Using more established corpus-based methods, we subsequently explore two top phrases - ‘human rights’ and ‘climate change’ that were identified as representative of the shifting thematic patterns. Our approach strikes a balance between the purely quantitative and qualitative methodologies and offers applied linguists new ways of exploring discourse in large collections of texts.