Toward a view of complementarity trust and policy influence effects of corporate social responsibility and corporate political activity

The extant literature argues that nonmarket strategies can establish, sustain, or enhance a firm’s competitive advantage. Less clear is how and why effective nonmarket strategies influence a firm’s competitiveness. Moreover, the extant literature tends to examine the two building blocks of nonmarket strategy—corporate social responsibility (CSR) and corporate political activity (CPA)—separately. In this article, we extend trust to the nonmarket environment. We analyze how CSR and CPA complement each other to create strong trust between firms and the polity, and how they consequently influence government policy. We show the mediating role of trust in policy influence, and argue that CSR and CPA should be aligned for the successful influence of salient government policy.

Sample size considerations in active-control non-inferiority trials with binary data based on the odds ratio

This paper presents an approximate closed form sample size formula for determining non-inferiority in active-control trials with binary data. We use the odds-ratio as the measure of the relative treatment effect, derive the sample size formula based on the score test and compare it with a second, well-known formula based on the Wald test. Both closed form formulae are compared with simulations based on the likelihood ratio test. Within the range of parameter values investigated, the score test closed form formula is reasonably accurate when non-inferiority margins are based on odds-ratios of about 0.5 or above and when the magnitude of the odds ratio under the alternative hypothesis lies between about 1 and 2.5. The accuracy generally decreases as the odds ratio under the alternative hypothesis moves upwards from 1. As the non-inferiority margin odds ratio decreases from 0.5, the score test closed form formula increasingly overestimates the sample size irrespective of the magnitude of the odds ratio under the alternative hypothesis. The Wald test closed form formula is also reasonably accurate in the cases where the score test closed form formula works well. Outside these scenarios, the Wald test closed form formula can either underestimate or overestimate the sample size, depending on the magnitude of the non-inferiority margin odds ratio and the odds ratio under the alternative hypothesis. Although neither approximation is accurate for all cases, both approaches lead to satisfactory sample size calculation for non-inferiority trials with binary data where the odds ratio is the parameter of interest.

The new localism, anti-political development machines, and the role of planning consultants: lessons from London's South Bank

This paper draws on a study of the politics of development planning in London’s South Bank to examine wider trends in the governance of contemporary cities. It assesses the impacts and outcomes of so-called new localist reforms and argues that we are witnessing two principal trends. First, governance processes are increasingly dominated by anti-democratic development machines, characterized by new assemblages of public- and private-sector experts. These machines reflect and reproduce a type of development politics in which there is a greater emphasis on a pragmatic realism and a politics of delivery. Second, the presence of these machines is having a significant impact on the politics of planning. Democratic engagement is not seen as the basis for new forms of localism and community control. Instead, it is presented as a potentially disruptive force that needs to be managed by a new breed of skilled private-sector consultant. The paper examines these wider shifts in urban politics before focusing on the connections between emerging development machines and local residential and business communities. It ends by highlighting some of the wider implications of change for democratic modes of engagement and nodes of resistance in urban politics.

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.

Translation practices in political institutions: a comparison of national, supranational, and non-governmental organisations

This paper explores the settings and practices of translation at three types of political institutions, i.e. national, supranational, and non-governmental organisations. The three institutions are the translation service of the German Foreign Office, the translation department of the European Central Bank, and translation provision by the non-governmental organisation Amnesty International. The three case studies describe the specific translation practices in place at these institutions and illustrate some characteristic translation strategies. In this way, we reflect on how different translation practices can impact on translation agency and how these practices in turn are influenced by the type of institution and its organisational structure. The article also aims to explore to which extent the characteristics of collectivity, anonymity and standardisation, and of institutional translation as self-translation are applicable to the institutions under discussion.

An investigation of the shortcomings of the CONSORT 2010 statement for the reporting of group sequential randomised controlled trials: a methodological systematic review

Background It can be argued that adaptive designs are underused in clinical research. We have explored concerns related to inadequate reporting of such trials, which may influence their uptake. Through a careful examination of the literature, we evaluated the standards of reporting of group sequential (GS) randomised controlled trials, one form of a confirmatory adaptive design. Methods We undertook a systematic review, by searching Ovid MEDLINE from the 1st January 2001 to 23rd September 2014, supplemented with trials from an audit study. We included parallel group, confirmatory, GS trials that were prospectively designed using a Frequentist approach. Eligible trials were examined for compliance in their reporting against the CONSORT 2010 checklist. In addition, as part of our evaluation, we developed a supplementary checklist to explicitly capture group sequential specific reporting aspects, and investigated how these are currently being reported. Results Of the 284 screened trials, 68(24%) were eligible. Most trials were published in “high impact” peer-reviewed journals. Examination of trials established that 46(68%) were stopped early, predominantly either for futility or efficacy. Suboptimal reporting compliance was found in general items relating to: access to full trials protocols; methods to generate randomisation list(s); details of randomisation concealment, and its implementation. Benchmarking against the supplementary checklist, GS aspects were largely inadequately reported. Only 3(7%) trials which stopped early reported use of statistical bias correction. Moreover, 52(76%) trials failed to disclose methods used to minimise the risk of operational bias, due to the knowledge or leakage of interim results. Occurrence of changes to trial methods and outcomes could not be determined in most trials, due to inaccessible protocols and amendments. Discussion and Conclusions There are issues with the reporting of GS trials, particularly those specific to the conduct of interim analyses. Suboptimal reporting of bias correction methods could potentially imply most GS trials stopping early are giving biased results of treatment effects. As a result, research consumers may question credibility of findings to change practice when trials are stopped early. These issues could be alleviated through a CONSORT extension. Assurance of scientific rigour through transparent adequate reporting is paramount to the credibility of findings from adaptive trials. Our systematic literature search was restricted to one database due to resource constraints.

No country for honest men: political philosophers and real politics

There are limits on the duty to tell the truth. Sometimes, because of the undesirable consequences of honesty, we are morally required not to reveal certain truths and can even be required to lie. In this article, we explore the implications of this uncontroversial claim for the practice of political philosophers. We argue that, given the consequences of misunderstandings and misrepresentations that might occur, political philosophers will sometimes be under a moral duty not to disseminate their research and, in highly exceptional cases, have a moral duty to lie outright.

Introduction: the legacy of Greek political thought

This Introduction offers context for the individual papers by examining the intersections and productive tensions between political thought and classical reception studies. While Plato and Aristotle have long been privileged interlocutors for political philosophers, classical reception studies has pluralised both this ancient canon and given rise to a more complex understanding of the modern heirs of ancient political thought. Similarly, the insights of studying the history of political texts and ideas across a longer tradition calls into question the fixity of concepts such as democracy, empire and political freedom. Indeed, we query the very notion of tradition by emphasising how the past has been repeatedly constructed and reconstructed in divergent modern political discourses and conversely how modern political theories and realities have been shaped and reshaped by an idea of antiquity. The Introduction closes with a brief survey of the collected papers.

Big social data and political sentiment: the tweet stream during the UK General Election 2015 campaign

The General Election for the 56th United Kingdom Parliament was held on 7 May 2015. Tweets related to UK politics, not only those with the specific hashtag ”#GE2015”, have been collected in the period between March 1 and May 31, 2015. The resulting dataset contains over 28 million tweets for a total of 118 GB in uncompressed format or 15 GB in compressed format. This study describes the method that was used to collect the tweets and presents some analysis, including a political sentiment index, and outlines interesting research directions on Big Social Data based on Twitter microblogging.

The Golden Age returns: Virgil's fourth Eclogue in the political panegyric of the Italian courts

E. H. Gombrich and others have analysed the uses made of language and imagery from Virgil's famous fourth Eclogue in panegyrical writing by partisans of the Medici dynasty in Florence. This study examines the appropriation of the theme of the returning Golden Age and related motifs from the fourth Eclogue in other Italian courts during the same period, by supporters of the Visconti and Sforza of Milan, the Gonzaga of Mantua, Leonello d'Este and his successors in Ferrara, and the Bentivoglio of Bologna, among others. The deployment of this Virgilian material in political panegyric is seen to be a central element in the self-definition and self-promotion of dynastic rulers throughout the peninsula.

Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials

Background Appropriately conducted adaptive designs (ADs) offer many potential advantages over conventional trials. They make better use of accruing data, potentially saving time, trial participants, and limited resources compared to conventional, fixed sample size designs. However, one can argue that ADs are not implemented as often as they should be, particularly in publicly funded confirmatory trials. This study explored barriers, concerns, and potential facilitators to the appropriate use of ADs in confirmatory trials among key stakeholders. Methods We conducted three cross-sectional, online parallel surveys between November 2014 and January 2015. The surveys were based upon findings drawn from in-depth interviews of key research stakeholders, predominantly in the UK, and targeted Clinical Trials Units (CTUs), public funders, and private sector organisations. Response rates were as follows: 30(55 %) UK CTUs, 17(68 %) private sector, and 86(41 %) public funders. A Rating Scale Model was used to rank barriers and concerns in order of perceived importance for prioritisation. Results Top-ranked barriers included the lack of bridge funding accessible to UK CTUs to support the design of ADs, limited practical implementation knowledge, preference for traditional mainstream designs, difficulties in marketing ADs to key stakeholders, time constraints to support ADs relative to competing priorities, lack of applied training, and insufficient access to case studies of undertaken ADs to facilitate practical learning and successful implementation. Associated practical complexities and inadequate data management infrastructure to support ADs were reported as more pronounced in the private sector. For funders of public research, the inadequate description of the rationale, scope, and decision-making criteria to guide the planned AD in grant proposals by researchers were all viewed as major obstacles. Conclusions There are still persistent and important perceptions of individual and organisational obstacles hampering the use of ADs in confirmatory trials research. Stakeholder perceptions about barriers are largely consistent across sectors, with a few exceptions that reflect differences in organisations’ funding structures, experiences and characterisation of study interventions. Most barriers appear connected to a lack of practical implementation knowledge and applied training, and limited access to case studies to facilitate practical learning. Keywords: Adaptive designs; flexible designs; barriers; surveys; confirmatory trials; Phase 3; clinical trials; early stopping; interim analyses