What matters most? Different stakeholder perspectives on estimands for an invented case study in COPD

In drug development, we ask ourselves which population, endpoint and treatment comparison should be investigated. In this context, we also debate what matters most to the different stakeholders that are involved in clinical drug development, for example, patients, physicians, regulators and payers. With the publication of draft ICH E9 addendum on estimands in 2017, we now have a common framework and language to discuss such questions in an informed and transparent way. This has led to the estimand discussion being a key element in study development, including design, analysis and interpretation of a treatment effect. At an invited session at the 2018 PSI annual conference, PSI hosted a role‐play debate where the aim of the session was to mimic a regulatory and payer scientific advice discussion for a COPD drug. Including role‐play views from an industry sponsor, a patient, a regulator and a payer. This paper presents the invented COPD case‐study design and considerations relating to appropriate estimands are discussed by each of the stakeholders from their differing viewpoints with the additional inclusion of a technical (academic) perspective. The rationale for each perspective on approaches for handling intercurrent events is presented, with a key emphasis on the application of while‐on‐treatment and treatment policy estimands in this context. It is increasingly recognised that the treatment effect estimated by the treatment policy approach may not always be of primary clinical interest and may not appropriately communicate to patients the efficacy they can expect if they take the treatment as directed.     

Local planning and global implementation: Foreign investment and urban development of Pudong, Shanghai

Competitive planning programmes for global integration have been created in cities throughout developed and developing countries during the past 2 decades. In China, global aspiration planning has been characterised by the establishment of Pudong New Area of Shanghai in 1990, with a group of foreign direct investment (FDI)-oriented themed zones targeting different types of global flows. Pudong very rapidly became a focus of FDI in the city, which extended to China as a whole in the 1990s, and now is further extended to playing a global role. However, spatial planning for the themed zones in Pudong has been limited in its scope to the physical design, land use, and the pattern of transport routes. This limited role of land use planning has been inadequate to coordinate the mutual engagement between global and local factors; however, an improved mechanism for coordinating planning has not yet emerged to replace it. The competitive and entrepreneurial approach of land management in conjunction with the imperatives of global firms has effectively diminished the original plan's intention that each zone should focus on particular industries, with each of them complementing the others.     

Disability and mortgage default: an Australian study

Debates on human rights and discrimination regarding housing and disability need to emphasise community care and inclusion as principles for improving policy. A qualitative study of Australian mortgage default reveals special difficulties for households with a member with a disability; that is, illness, impairment or injury limiting everyday activities and enduring for several months. Interviews showed that such households adopted similar strategies to other mortgagors with serious financial difficulties but tended to have fewer and less attractive options. Given the crisis in Australian disability welfare services and the 2010–2011 Productivity Commission inquiry recommending major reforms, these findings can inform policy.     

Contemporary Immigration Policy Orientations Among Dominant-Group Members in Western Europe

Predictors of immigration policy attitudes were investigated among members of receiving societies in large national probability samples in 15 Western European countries. We found that a considerable proportion of the variation in immigration policy orientations toward outgroups could be explained by self- and group interests and independent measures of perceived threat. Self-reported racism also contributed independently and significantly to these policy positions. It was concluded that a general framework of proximal self- and group-position indicators (Allport, 1954), perceived threat, and prejudice/racism was useful in predicting the immigrant policy orientations of dominant members of receiving societies across Western Europe. The meaning of these findings for future research on immigration policy orientations across, and especially within, European countries is discussed.     

New Agendas for Social Policy and Criminology: Globalization, Urbanism and the EmergingPost-Social Security State

The subjects of social policy and criminology have long been concerned with the criminalization and regulation of the poor. The premise of this paper is that in recent years new forms of criminalization and regulation have emerged that various authors, from both disciplines, have begun to theorize. The paper aims to contribute to this growing literature by bringing together diverse themes that deserve to be extensively discussed in conjunction with one another. These are: first, globalization; second, the changing nature of the state; third, the reorganization of space and time, especially at the urban level. It proceeds through examinations of some of the recent work of Jock Young, David Garland, Ramesh Mishra, Peter Taylor-Gooby and Zygmunt Bauman. It concludes that theoretical and empirical research should analyse the reorganization of space and time which is being effected by the "post-social security state" and it is this which constitutes the new agenda for social policy and criminology.     

Entrepreneurship – A Suitable Case for Sociological Treatment

Entrepreneurs are of great interest inside and outside the academic world. But there are considerable ambiguities and confusions about the nature of entrepreneurship among members of the public and entrepreneurship scholars alike, with the latter typically failing to locate entrepreneurial activities fully in their historical and societal contexts. Even work in the sociology of entrepreneurship is achieving less than might be expected in this respect. To overcome these problems it is helpful to return to basic sociological principles associated with Durkheim, Weber and Wright Mills and work with two newer sociological concepts; those of ‘institutional logics’ and ‘situated creativity’. Working in this way encourages us to drop entirely the analytical concept of ‘entrepreneur’ and to study, instead, ‘entrepreneurial action’– a concept which enables us to appreciate the relationship between the making of adventurous, creative or innovative exchanges in societies and both the organisational and the societal/institutional/historical settings in which these comes about – for better or worse.