A review and validation of overall survival extrapolation in health technology assessments of cancer immunotherapy by the National Institute for Health and Care Excellence: how did the initial best estimate compare to trial data subsequently made available?

Background: Validation of overall survival (OS) extrapolations of immune-checkpoint inhibitors (ICIs) during the National Institute for Health and Care Excellence (NICE) Single Technology Assessment (STA) process is limited due to data still maturing at the time of submission. Inaccurate extrapolation may lead to inappropriate decision-making. The availability of more mature trial data facilitates a retrospective analysis of the plausibility and validity of initial extrapolations. This study compares these extrapolations to subsequently available longer-term data.

Methods: A systematic search of completed NICE appraisals of ICIs from March 2000 to December 2017 was performed. A targeted search was also undertaken to procure published OS data from the pivotal clinical trials for each identified STA made available post-submission to NICE. Initial Kaplan-Meier curves and associated extrapolations from NICE documentation were extracted to compare the accuracy of OS projections versus the most mature data.

Results: The review identified 11 STAs, of which 10 provided OS data upon submission to NICE. The extrapolations undertaken considered parametric or piecewise survival models. Additional data cut-offs provided a mean of 18 months of OS beyond the end of the original data. Initial extrapolations typically under-estimated OS from the most mature data cut-off by 0.4–2.7%, depending on the choice of assessment method and use of the manufacturer- or ERG-preferred extrapolation.

Conclusion: Long-term extrapolation of OS is required for NICE STAs based on initial immature OS data. The results of this study demonstrate that the initial OS extrapolations employed by manufacturers and ERGs generally predicted OS reasonably well when compared to more mature data (when available), although on average they appeared to underestimate OS. This review and validation shows that, while the choice of OS extrapolation is uncertain, the methods adopted are generally aligned with later-published follow-up data and appear appropriate for informing HTA decisions.     

Foreign direct investment and vertical integration of production by Japanese multinationals in Thailand

We test the vertical model of foreign direct investment (FDI) empirically using firm level information on Japanese multinational activity in Thailand. These data allow us to investigate the effects of both home country (Japan) and host country (Thailand) characteristics on the inter-industry pattern of FDI. For 85 manufacturing industries over the period from 1985 to 1995, we find a positive influence of industry variation in skill intensity and market size in the host country and a negative effect of transport costs on the amount of FDI. These results provide strong direct econometric evidence of vertical integration of production across the countries. Journal of Comparative Economics 32 (4) (2004) 805–821.     

Predicting UK Business Cycle Regimes

This paper uses logistic regression to construct a one‐quarter ahead prediction model for classical business cycle regimes in the UK. The binary dependent variable is obtained by applying simple mechanical rules to date turning points in quarterly real GDP data from 1963 to 1999. Using a range of real and financial leading indicators, several parsimonious one‐quarter‐ahead models are developed for the GDP regimes, with model selection based on the SIC criterion. A real M4 variable is consistently found to have predictive content. One model that performs well combines this with nominal UK and German short‐term interest rates. The role of the latter emphasises the open nature of the UK economy.     

A research agenda for improving national Ecological Footprint accounts

Nation-level Ecological Footprint accounts are currently produced for more than 150 nations, with multiple calculations available for some nations. The data sets that result from these national assessments typically serve as the basis for Footprint calculations at smaller scales, including those for regions, cities, businesses, and individuals. Global Footprint Network's National Footprint Accounts, supported and used by more than 70 major organizations worldwide, contain the most widely used national accounting methodology today. The National Footprint Accounts calculations are undergoing continuous improvement as better data becomes available and new methodologies are developed. In this paper, a community of active Ecological Footprint practitioners and users propose key research priorities for improving national Ecological Footprint accounting. For each of the proposed improvements, we briefly review relevant literature, summarize the current state of debate, and suggest approaches for further development. The research agenda will serve as a reference for a large scale, international research program devoted to furthering the development of national Ecological Footprint accounting methodology.     

‘Hidden’ expatriates: international mobility in the United Arab Emirates as a challenge to current understanding of expatriation

Expatriates are often assumed to have enhanced terms and conditions and, because that makes them expensive, to be in key managerial or technical specialist roles. Employees who come from abroad and are in more manual or even menial roles are usually referred to as ‘migrants’. However, there are millions of people around the world who are not migrants, their intended sojourn in a foreign country is seen by them and their employers as temporary, but their employment contracts are far from advantageous compared with those of locals. These ‘hidden’ expatriates are brought into focus in the emerging Arab Gulf States. In some of these countries, the population consists mainly of expatriates, with the local population a small minority: These expatriates include many in lower‐management or manual or menial jobs. We demarcate these expatriates from organisationally assigned expatriates, self‐initiated expatriates and migrants. We use qualitative data from such expatriates in the United Arab Emirates to explore the issues this raises for governments, employers and the expatriates – and for our understanding of the phenomenon of expatriation.     

The Political Power of Big Business: A Response to Bell and Hindmoor

There has been a recent resurgence of interest in debates about the power of business (Culpepper 2011 Culpepper, P. (2011). Quiet Politics and Business Power: Corporate Control in Europe and Japan, Cambridge: Cambridge University Press. [Google Scholar]; Bell 2012 Bell, S. (2012). The Power of Ideas: The Ideational Mediation of the Structural Power of Business. International Studies Quarterly, 56(4), 661–73. doi: 10.1111/j.1468-2478.2012.00743.x[Crossref], [Web of Science ®] , [Google Scholar]) and Bell and Hindmoor (2013 Bell, S., Hindmoor, A. (2013). The Structural Power of Business and the Power of Ideas: The Strange Case of the Australian Mining Tax. New Political Economy, ,forthcoming. Available from: http://dx.doi.org/10.1080/13563467.2013.796452 [19 (3), pp. 470–486, cross-references updated] [Google Scholar]) make an important, theoretically informed, but empirically rooted, contribution to that debate. In this response, we address both aspects of their contribution, arguing that their treatment of Lindblom is partial and, consequently, so is their explanation of the case. As such, we largely rely on their narrative of the evolution of the Australian mining tax, focusing first on critically examining Bell and Hindmoor's theoretical position, before turning to their analysis of the case.     

The Development and Diffusion of Radical Technological Innovation: The Role of Bus Demonstration Projects in Commercializing Fuel Cell Technology

North American, European and Japanese governments have legislated to control Greenhouse Gas emissions and have promoted alternative technology as part of strategies to address climate change. Governments worldwide have sought to encourage adoption of alternative automotive technology by funding demonstrations and in-service trials. Among other initiatives the automotive industry has explored applications of a radical technological innovation—fuel cells—to power a range of vehicles from forklifts to buses. This paper examines the rationale and actions of various stakeholders to facilitate adoption of fuel cell technology in vehicles through a specific market segment—that of fuel cell buses (FCBs)—and explores the progress of FCB projects in North America, Europe and Japan. It examines the role of demonstration projects and highlights the complexity of the relationship between government and developers, and the multifarious and conflicting objectives of industry players that inhibit progress.