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

Risk taking of executives under different incentive contracts: experimental evidence

Classic financial agency theory recommends compensation through stock options rather than shares to counteract excessive risk aversion in agents. In a setting where any kind of risk taking is suboptimal for shareholders, we show that excessive risk taking may occur for one of two reasons: risk preferences or incentives. Even when compensated through restricted company stock, experimental CEOs take large amounts of excessive risk. This contradicts classical financial theory, but can be explained through risk preferences that are not uniform over the probability and outcome spaces, and in particular, risk seeking for small probability gains and large probability losses. Compensation through options further increases risk taking as expected. We show that this effect is driven mainly by the personal asset position of the experimental CEO, thus having deleterious effects on company performance.

Are existing biodiversity conservation strategies appropriate in a changing climate?

Many countries have conservation plans for threatened species, but such plans have generally been developed without taking into account the potential impacts of climate change. Here, we apply a decision framework, specifically developed to identify and prioritise climate change adaptation actions and demonstrate its use for 30 species threatened in the UK. Our aim is to assess whether government conservation recommendations remain appropriate under a changing climate. The species, associated with three different habitats (lowland heath, broadleaved woodland and calcareous grassland), were selected from a range of taxonomic groups (primarily moths and vascular plants, but also including bees, bryophytes, carabid beetles and spiders). We compare the actions identified for these threatened species by the decision framework with those included in existing conservation plans, as developed by the UK Government's statutory adviser on nature conservation. We find that many existing conservation recommendations are also identified by the decision framework. However, there are large differences in the spatial prioritisation of actions when explicitly considering projected climate change impacts. This includes recommendations for actions to be carried out in areas where species do not currently occur, in order to allow them to track movement of suitable conditions for their survival. Uncertainties in climate change projections are not a reason to ignore them. Our results suggest that existing conservation plans, which do not take into account potential changes in suitable climatic conditions for species, may fail to maximise species persistence. Comparisons across species also suggest a more habitat-focused approach could be adopted to enable climate change adaptation for multiple species.

Construction contracts: law and management. 5th edition

The fifth edition of this best-selling textbook has been thoroughly revised to provide the most up-to-date and comprehensive coverage of the legislation, administration and management of construction contracts. It now includes comparison of working with JCT, NEC3 and FIDIC contracts, throughout. In line with new thinking in construction management research, this authoritative guide is essential reading for every construction undergraduate and is an extremely useful source of reference for practitioners.