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

A data collection case study supporting requirements oriented prediction and management in software developments

Consider the statement "this project should cost X and has risk of Y". Such statements are used daily in industry as the basis for making decisions. The work reported here is part of a study aimed at providing a rational and pragmatic basis for such statements. Of particular interest are predictions made in the requirements and early phases of projects. A preliminary model has been constructed using Bayesian Belief Networks and in support of this, a programme to collect and study data during the execution of various software development projects commenced in May 2002. The data collection programme is undertaken under the constraints of a commercial industrial regime of multiple concurrent small to medium scale software development projects. Guided by pragmatism, the work is predicated on the use of data that can be collected readily by project managers; including expert judgements, effort, elapsed times and metrics collected within each project.

Digital infrastructure and changing practices in engineering design

New skills are needed to compete, as integrated software solutions provide a digital infrastructure for projects. This changes the practice of information management and engineering design on next generation projects.

Adaptive project planning and management based on best practices - COBRA system

Planning a project with proper considerations of all necessary factors and managing a project to ensure its successful implementation will face a lot of challenges. Initial stage in planning a project for bidding a project is costly, time consuming and usually with poor accuracy on cost and effort predictions. On the other hand, detailed information for previous projects may be buried in piles of archived documents which can be increasingly difficult to learn from the previous experiences. Project portfolio has been brought into this field aiming to improve the information sharing and management among different projects. However, the amount of information that could be shared is still limited to generic information. This paper, we report a recently developed software system COBRA to automatically generate a project plan with effort estimation of time and cost based on data collected from previous completed projects. To maximise the data sharing and management among different projects, we proposed a method of using product based planning from PRINCE2 methodology. (Automated Project Information Sharing and Management System -�COBRA) Keywords: project management, product based planning, best practice, PRINCE2

A multi-scale framework for strategic management of diffuse pollution

A multi-scale framework for decision support is presented that uses a combination of experiments, models, communication, education and decision support tools to arrive at a realistic strategy to minimise diffuse pollution. Effective partnerships between researchers and stakeholders play a key part in successful implementation of this strategy. The Decision Support Matrix (DSM) is introduced as a set of visualisations that can be used at all scales, both to inform decision making and as a communication tool in stakeholder workshops. A demonstration farm is presented and one of its fields is taken as a case study. Hydrological and nutrient flow path models are used for event based simulation (TOPCAT), catchment scale modelling (INCA) and field scale flow visualisation (TopManage). One of the DSMs; The Phosphorus Export Risk Matrix (PERM) is discussed in detail. The PERM was developed iteratively as a point of discussion in stakeholder workshops, as a decision support and education tool. The resulting interactive PERM contains a set of questions and proposed remediation measures that reflect both expert and local knowledge. Education and visualisation tools such as GIS, risk indicators, TopManage and the PERM are found to be invaluable in communicating improved farming practice to stakeholders. (C) 2008 Elsevier Ltd. All rights reserved.

Financing road transport infrastructure

In the UK, public expenditure on transport infrastructure is nearly £6 billion for the past few years. Over £500 million per year were spent on bridge assessment and strengthening and reducing the backlog of road requiring maintenance. A further £200 million a year will be spent on keeping the safe operation of the network and efficiently through day to day maintenance, lighting and signing . The Department of Transport is planning to extend private sector experience in road management and operation by introducing Design, Build, Finance and Operate (DBFO) This paper investigates the different ways of financing road transport infrastructure including road pricing, private finance in transport infrastructure, the role of the private sector, Design, Build, Finance and Operate (DBFO) schemes, the benefits and problems of such schemes. The paper considers planning gain as a means of financing transport infrastructure with examples of developers to fund link road building and improvements to the local planning system

Intellectual property management in M&A transactions

Purpose – The purpose of this paper is to focus on the intellectual property (IP) aspects of mergers and acquisitions (M&A) transactions. Design/methodology/approach – A holistic approach is proposed that embraces IP as an integral part of the M&A process in the form of a roadmap for the strategic and purposeful management of IP assets in M&A deals. Findings – Addressing IP issues in transactions in isolation can lead to undesirable consequences (e.g. considerable costs for unplanned purchases of rights). IP due diligence and IP integration project processes can be automated using collaborative software solutions. Thereby, risk can be reduced through the creation of a high level of transparency and predefined responsibilities. Practical implications – Although the proposed IP management framework is based on intellectual property matters relevant to German jurisdiction, conclusions derived and the proposed roadmap are transferable to other jurisdictions and hence have a broader relevance. Evidence for this is provided by the successful application of the roadmap in the context of the multinational transaction stated above. Originality/value – This paper is based on the authors' collective experience, insight and reflected observation of M&A practice gained in advisory M&A roles in management consultancies over a period of more than a decade. The paper summarizes the authors' reflections and observations and brings these into the context of the current management literature. Moreover, this paper builds on earlier published research.

Requirements for building information modeling based lean production management systems for construction

Smooth flow of production in construction is hampered by disparity between individual trade teams' goals and the goals of stable production flow for the project as a whole. This is exacerbated by the difficulty of visualizing the flow of work in a construction project. While the addresses some of the issues in Building information modeling provides a powerful platform for visualizing work flow in control systems that also enable pull flow and deeper collaboration between teams on and off site. The requirements for implementation of a BIM-enabled pull flow construction management software system based on the Last Planner System™, called ‘KanBIM’, have been specified, and a set of functional mock-ups of the proposed system has been implemented and evaluated in a series of three focus group workshops. The requirements cover the areas of maintenance of work flow stability, enabling negotiation and commitment between teams, lean production planning with sophisticated pull flow control, and effective communication and visualization of flow. The evaluation results show that the system holds the potential to improve work flow and reduce waste by providing both process and product visualization at the work face.

Stock assessment for fishery management - A framework guide to the stock assessment tools of the Fisheries Management Science Programme (FMSP)

This document provides guidelines for fish stock assessment and fishery management using the software tools and other outputs developed by the United Kingdom's Department for International Development's Fisheries Management Science Programme (FMSP) from 1992 to 2004. It explains some key elements of the precautionary approach to fisheries management and outlines a range of alternative stock assessment approaches that can provide the information needed for such precautionary management. Four FMSP software tools, LFDA (Length Frequency Data Analysis), CEDA (Catch Effort Data Analysis), YIELD and ParFish (Participatory Fisheries Stock Assessment), are described with which intermediary parameters, performance indicators and reference points may be estimated. The document also contains examples of the assessment and management of multispecies fisheries, the use of Bayesian methodologies, the use of empirical modelling approaches for estimating yields and in analysing fishery systems, and the assessment and management of inland fisheries. It also provides a comparison of length- and age-based stock assessment methods. A CD-ROM with the FMSP software packages CEDA, LFDA, YIELD and ParFish is included.

HDC poinsettia tracker: flexible graphical tracking software

Growing pot poinsettia and similar crops involves careful crop monitoring and management to ensure that height specifications are met. Graphical tracking represents a target driven approach to decision support with simple interpretation. HDC (Horticultural Development Council) Poinsettia Tracker implements a graphical track based on the Generalised Logistic Curve, similar to that of other tracking packages. Any set of curve parameters can be used to track crop progress. However, graphical tracks must be expected to be site and cultivar specific. By providing a simple Curve fitting function, growers can easily develop their own site and variety specific ideal tracks based on past records with increasing quality as more seasons' data are added. (C) 2009 Elsevier B.V. All rights reserved.

Evidence of systematic approaches to innovation in facilities management

Purpose – This paper seeks to examine the nature of “service innovation” in the facilities management (FM) context. It reviews recent thinking on “service innovation” as distinct from “product innovation”. Applying these contemporary perspectives it describes UK case studies of 11 innovations in different FM organisations. These include both in-house client-based innovations and third-party innovations. Design/methodology/approach – The study described in the paper encompasses 11 different innovations that constitute a mix of process, product and practice innovations. All of the innovations stem from UK-based organisations that were subject to in-depth interviews regarding the identification, screening, commitment of resources and implementation of the selected innovations. Findings – The research suggested that service innovation is highly active in the UK FM sector. However, the process of innovation rarely followed a common formalized path. Generally, the innovations were one-shot commitments at the early stage. None of the innovations studied failed to proceed to full adoption stage. This was either due to the reluctance of participating organisations to volunteer “tested but unsuccessful” innovations or the absence of any trial methods that might have exposed an innovations shortcomings. Research limitations/implications – The selection of innovations was restricted to the UK context. Moreover, the choice of innovations was partly determined by the innovating organisation. This selection process appeared to emphasise “one-shot” high profile technological innovations, typically associated with software. This may have been at the expense of less resource intensive, bottom-up innovations. Practical implications – This paper suggests that there is a role for “research and innovation” teams within larger FM organisations, whether they are client-based or third-party. Central to this philosophy is an approach that is open to the possibility of failure. The innovations studied were risk averse with a firm commitment to proceed at the early stage. Originality/value – This paper introduces new thinking on the subject of “service innovation” to the context of FM. It presents research and development as a planned solution to innovation. This approach will enable service organisations to fully test and exploit service innovations.