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In clinical practice, an objective of safety management is to identify preventable causes of adverse events to avoid the incidents from recurring. Likewise, in the field of clinical research adequate methods to investigate incidents that impair the quality of a clinical trial are needed. Understanding the causes of errors and undesirable incidents can help guarantee participant safety, improve the practices of research coordinators, investigators, and clinical research assistants and help to minimize research costs. Here, we present the main features of our Incident Feedback Committees (IFC) in clinical research, with outcomes over 5 years. Methods: The IFC has adapted the ALARM and ORION post-event methods with investigations focused on 'the incidents' occurring during research studies. It sought the root causes contributing to these incidents and proposed corrective actions. Results: Since our IFC was set up in 2015 it has examined 52 incidents from nine studies. The most frequent causes mainly concerned the working environment (54%). Most incidents had two or more causes. Some corrective actions were planned for ongoing or future studies. Conclusion: IFCs provide a useful and much-appreciated method of analysing incidents in the performance of clinical research. A multicentre study is needed to evaluate the effect of IFCs on the quality of an establishment's clinical research, at the individual level (patient safety) and also at the system level (changes in the organization of tasks). [ABSTRACT FROM AUTHOR]

This paper analyses the use of the term 'market research' in a contemporary context. Although the term is well established as an industry definition, its use and meaning have become increasingly contested. This study brings together empirical data from a range of sources that reflect key stakeholders within the market research sector. Findings suggest that the term 'market research' has become increasingly marginalised amongst these key stakeholders. Few of the leading research firms use this term to describe their core activity, and data suggest that wider use of the term has declined over the past decade. Where 'market research' is used, the term is typically demoted to describing a set of skills rather than a strategic concept around adding value. A number of explanations for this are explored, including isomorphism among research firms, the role of research in generating value, and the broader economic context in which research takes place. Finally, the paper considers whether continuing use of the term is beneficial to the future success of the research sector. [ABSTRACT FROM AUTHOR]

The research and development (R&D) ecosystem has evolved over the past decade to include pandemic infectious diseases, building on experience from multiple recent outbreaks. Outcomes of this evolution have been particularly evident during the COVID-19 pandemic with accelerated development of vaccines and monoclonal antibodies, as well as novel clinical trial designs. These products were developed, trialled, manufactured, and authorised for use in several countries within a year of the pandemic's onset. Many gaps remain, however, that must be bridged to establish a truly efficient and effective end-to-end R&D preparedness and response ecosystem. Foremost among them is a global financing system. In addition, important changes are required for multiple aspects of enabling sciences and product development. For each of these elements we identify priorities for improved and faster functionality. There will be no better time than now to seriously address these needs, however difficult, as the ravages of COVID-19 continue to accelerate with devastating health, social, and economic consequences for the entire community of nations. [ABSTRACT FROM AUTHOR]

Background: At the beginning of the 2000s, Norwegian research in nursing and allied health disciplines was described as weak. Since 2007, the Northern Norway Regional Health Authority has had a strategic focus on enhancing health research. Objective: The objective of this project was to evaluate whether the Northern Norway Regional Health Authority's research investment has given results. We have examined research activity, the allocation of research funding, research outputs and facilitating factors for research to be conducted by health researchers (excluding doctors and dentists) in the health trusts. Method: The survey took place in four health trusts under the Northern Norway Regional Health Authority. In the survey, we used a multi-method approach and a variety of data sources. Quantitative mapping based on research administrative data and systematic searches for published scientific output registered in journal databases were used together with data from a survey conducted among health researchers and research fellows in 2015. Results: In the period 2008-2015, there was an increase in the number of research fellows, researchers and published scientific output in the health trusts. Competence enhancement has been greatest in nursing and physiotherapy. Researchers and research fellows have contributed to multi-disciplinary research, using a broad range of methodological approaches with a preponderance of qualitative methods. On average, 29 per cent of the articles published in the period were published in level 2 journals. The Northern Norway Regional Health Authority has been the main funding source for the research. The respondents reported time pressure, lack of funding, research culture and adaptation for research as obstacles to conducting research. Conclusion: There has been a positive development in and strengthening of health research and research-based competence in the Northern Norway Regional Health Authority during the relevant period of time. The results indicate that strategic investment in health research has had a positive effect, and that a similar focus is also recommended for other health authorities. [ABSTRACT FROM AUTHOR]

Trials are in development and underway to examine potential interventions for treatment and prophylaxis of coronavirus disease 2019 (COVID-19). How should we think about offering payment to participants in these trials? Payment for research participation is ethically contentious even under ideal circumstances. Here, we review 3 functions of research payment-reimbursement, compensation, and incentive-and identify heightened and novel ethical concerns in the context of a global pandemic. We argue that COVID-19 trial participants should usually be offered reimbursement for research-related expenses, and compensation for their time and effort, as for other types of research under usual circumstances. Given increased risk of undue influence against pandemic background conditions, incentive payment should be avoided unless essential to recruitment and retention in important trials whose social value outweighs this risk. Where essential, however, incentives can be ethically permissible, so long as reasonable efforts are made to minimize the possibility of undue influence. [ABSTRACT FROM AUTHOR]

Value of information (VOI) analyses can help policy makers make informed decisions about whether to conduct and how to design future studies. Historically a computationally expensive method to compute the expected value of sample information (EVSI) restricted the use of VOI to simple decision models and study designs. Recently, 4 EVSI approximation methods have made such analyses more feasible and accessible. Members of the Collaborative Network for Value of Information (ConVOI) compared the inputs, the analyst's expertise and skills, and the software required for the 4 recently developed EVSI approximation methods. Our report provides practical guidance and recommendations to help inform the choice between the 4 efficient EVSI estimation methods. More specifically, this report provides: (1) a step-by-step guide to the methods' use, (2) the expertise and skills required to implement the methods, and (3) method recommendations based on the features of decision-analytic problems. [ABSTRACT FROM AUTHOR]

Introduction: Pharmaceutical research and development (R&D) is costly and only a minority of patients can access innovative medicines due to affordability constraints. Value-added medicines (VAMs) can offer potential benefits at significantly lower R&D costs.Areas Covered: VAMs may address different health care needs and problems, including off-label use of medicines, poor patient adherence, problems related to polypharmacy, need for home and/or personalized health care services. However, several barriers prevent societies from maximizing the benefits of incremental innovation related to VAMs. Generic manufacturers have limited budget and experience to demonstrate the value of new VAMs. Current market exclusivity options do not efficiently exclude freeridership and do not guarantee a return on investment for VAM innovators. Value propositions of VAMs are limitedly consistent with current HTA frameworks, consequently, incremental innovation is not acknowledged, nor rewarded with differential pricing by payers. Moreover, VAMs are often perceived solely as generic medicines by prescribers.Expert Opinion: Current practices may need to be reconsidered to exploit the full societal benefit of VAMs, including more efficient policies to guarantee market exclusivity for incremental innovation, acknowledgment of a fair price premium based on a specific value framework and the acceptance of low-cost evidence generation methods. [ABSTRACT FROM AUTHOR]

This commentary makes the case for increased investment in the development of improved contraceptive and multipurpose prevention technologies (MPTs) that better meet the needs and preferences of users, increase the methods' acceptability and use, and ultimately decrease unintended pregnancy. Methods that are inexpensive, user-controlled, and shelf-stable could help address challenges posed by weak supply chains and healthcare systems. New MPTs that protect against pregnancy and sexually transmitted infections (STIs), including HIV, could simultaneously address multiple sexual and reproductive health needs. Although promising scientific leads exist, the high costs and risks associated with contraceptive development has contributed to underinvestment. The public sector, philanthropies, and the pharmaceutical industry have decreased or eliminated investments in contraceptive research and development (R&D) in recent decades. Greater financial and policy support are required for the eventual introduction of new and improved contraceptives and MPTs. [ABSTRACT FROM AUTHOR]

The role of research-embedded higher education is regarded as one of the driving forces of any growing economy. Higher education institutions (HEIs) are recognized, among their peers, for their quality of research outcome. Hence, with growing emphasis on research worldwide, HEIs strive hard to improve their research output. The proposed study endeavors to make a longitudinal comparison of research outcome of HEIs from the BRICS Nations, with special emphasis on management and its allied discipline. As the centers of ancient wisdom and learning, BRICS nations have many things in common. They are envisioned as the economies that will drive growth in the future. Quantitative data from the Elsevier's Scopus database were used for comparative analysis. The findings of the study provide ample insights to discuss the key areas to be improved, to provide research impetus and developing policies to scale up research in management. [ABSTRACT FROM AUTHOR]

The article offers information on the prevention and treatment related to the tuberculosis. Topics discussed include information on the declines in tuberculosis deaths due to medical advancement; discussions on the strategies to identify people with active disease in high-risk populations; and the information on the global efforts to end tuberculosis have been undermined by insufficient political will and financial investments.

Objective: The expected value of sample information (EVSI) quantifies the economic benefit of reducing uncertainty in a health economic model by collecting additional information. This has the potential to improve the allocation of research budgets. Despite this, practical EVSI evaluations are limited partly due to the computational cost of estimating this value using the gold-standard nested simulation methods. Recently, however, Heath et al. developed an estimation procedure that reduces the number of simulations required for this gold-standard calculation. Up to this point, this new method has been presented in purely technical terms.Study Design: This study presents the practical application of this new method to aid its implementation. We use a worked example to illustrate the key steps of the EVSI estimation procedure before discussing its optimal implementation using a practical health economic model.Methods: The worked example is based on a three-parameter linear health economic model. The more realistic model evaluates the cost-effectiveness of a new chemotherapy treatment, which aims to reduce the number of side effects experienced by patients. We use a Markov model structure to evaluate the health economic profile of experiencing side effects.Results: This EVSI estimation method offers accurate estimation within a feasible computation time, seconds compared to days, even for more complex model structures. The EVSI estimation is more accurate if a greater number of nested samples are used, even for a fixed computational cost.Conclusions: This new method reduces the computational cost of estimating the EVSI by nested simulation. [ABSTRACT FROM AUTHOR]

The 2013 Breast Cancer Campaign gap analysis established breast cancer research priorities without a specific focus on surgical research or the role of surgeons on breast cancer research. This Review aims to identify opportunities and priorities for research in breast surgery to complement the 2013 gap analysis. To identify these goals, research-active breast surgeons met and identified areas for breast surgery research that mapped to the patient pathway. Areas included diagnosis, neoadjuvant treatment, surgery, adjuvant therapy, and attention to special groups (eg, those receiving risk-reducing surgery). Section leads were identified based on research interests, with invited input from experts in specific areas, supported by consultation with members of the Association of Breast Surgery and Independent Cancer Patients' Voice groups. The document was iteratively modified until participants were satisfied that key priorities for surgical research were clear. Key research gaps included issues surrounding overdiagnosis and treatment; optimising treatment options and their selection for neoadjuvant therapies and subsequent surgery; reducing rates of re-operations for breast-conserving surgery; generating evidence for clinical effectiveness and cost-effectiveness of breast reconstruction, and mechanisms for assessing novel interventions; establishing optimal axillary management, especially post-neoadjuvant treatment; and defining and standardising indications for risk-reducing surgery. We propose strategies for resolving these knowledge gaps. Surgeons are ideally placed for a central role in breast cancer research and should foster a culture of engagement and participation in research to benefit patients and health-care systems. Development of infrastructure and surgical research capacity, together with appropriate allocation of research funding, is needed to successfully address the key clinical and translational research gaps that are highlighted in this Review within the next two decades. [ABSTRACT FROM AUTHOR]

Background: There is a need for high quality research to improve perioperative patient care in Africa. The aim of this study was to understand the particular barriers to clinical research in this environment.Methods: We conducted an electronic survey of African Surgical Outcomes Study (ASOS) investigators, including 29 quantitative Likert scale questions and eight qualitative questions with subsequent thematic analysis. Protocol compliant and non-compliant countries were compared according to WHO statistics for research and development, health workforce data, and world internet statistics.Results: Responses were received from 134/418 of invited researchers in 24/25 (96%) of participating countries, and three non-participating countries. Barriers included lack of a dedicated research team (47.7%), reliable internet access (32.6%), staff skilled in research (31.8%), and team commitment (23.8%). Protocol compliant countries had significantly more physicians per 1000 population (4 vs 0.9, P<0.01), internet penetration (38% vs 28%, P=0.01) and published clinical trials (1461 vs 208, P<0.01) compared with non-compliant countries. Facilitators of research included establishing a research culture (86.9%), simple data collection tools (80%), and ASOS team interaction (77.9%). Most participants are interested in future research (93.8%). Qualitative data reiterated human resource, financial resource, and regulatory barriers. However, the desire to contribute to an African collaboration producing relevant data to improve patient outcomes was expressed strongly by ASOS investigators.Conclusions: Barriers to successful participation in ASOS related to resource limitations and not motivation of the clinician investigators. Practical solutions to individual barriers may increase the success of multi-centre perioperative research in Africa. [ABSTRACT FROM AUTHOR]

In Australia, along with many other countries, limited guidance or other support strategies are currently available to researchers, institutional research ethics committees, and others responsible for making decisions about whether to return genomic findings with potential value to participants or their blood relatives. This lack of guidance results in onerous decision-making burdens—traversing technical, interpretative, and ethical dimensions—as well as uncertainty and inconsistencies for research participants. This article draws on a recent targeted consultation conducted by the Australian National Health and Medical Research Council to put forward strategies for supporting return of finding decision-making. In particular, we propose a pyramid of decision-making support: decision-making guidelines, technical and interpretative assistance, and ethical assistance for intractable “tough” cases. Each step of the pyramid involves an increasing level of regulatory involvement and applies to a smaller subsection of genomic research findings. Implementation of such strategies would facilitate a growing evidence base for return of finding decisions, thereby easing the financial, time, and moral burdens currently placed on researchers and other relevant decision-makers while also improving the quality of such decisions and, consequently, participant outcomes. [ABSTRACT FROM AUTHOR]

ABSTRACT: The papers in this volume were published through a Registration‐based Editorial Process (REP). Authors submitted proposals to gather and analyze data; successful proposals were guaranteed publication as long as the authors lived up to their commitments, regardless of whether results supported their predictions. To understand how REP differs from the Traditional Editorial Process (TEP), we analyze the papers themselves; conference comments; a survey of conference authors, reviewers, and attendees; and a survey of authors who have successfully published under TEP. We find that REP increases up‐front investment in planning, data gathering, and analysis, but reduces follow‐up investment after results are known. This shift in investment makes individual results more reproducible, but leaves articles less thorough and refined. REP could be improved by encouraging selected forms of follow‐up investment that survey respondents believe are usually used under TEP to make papers more informative, focused, and accurate at little risk of overstatement. [ABSTRACT FROM AUTHOR]

Haack begins with an exposition of Peirce's work on what he calls "the economy of research" (§1); then locates this work on the much larger map of his ideas about the factors that advance inquiry, and those that impede or block it (§2); suggests how all this relates to his ideas about the intergenerational community of inquirers (§3); and finally turns to the relevance of these ideas to the state of universities today (§4). Quoting Peirce's observation that his account of the economy of research "rests on the supposition that the object of investigation is the ascertainment of truth," but that "when an investigation is made [instead] for the purpose of attaining personal distinction, the economics of the problem are entirely different," Haack argues that this helps us understand why the present incentive structure of universities—which discourages serious intellectual work and encourages self-promotion—is so perverse. [ABSTRACT FROM AUTHOR]

Nominalism seems natural for defending a decent economy of research. However such a program may and has been achieved by such a strongly realistic pragmatism as the one endorsed by Peirce: he shows that there is no risk of "blocking inquiry", no tension between adopting a cost-benefit program and aiming at truth and knowledge, provided, on the negative side , our economy of research is able to stress the impossible reduction of theoretical matters to vital ones, the impossible assimilation of epistemic virtues to mere ethical virtues; and on the positive side , it is able to embrace a strong conception of normative rationality and epistemic virtues, make room as much to "uberty" degrees of belief, propensities as to validity, full-fledged justifications, absolute certainties and mere practical concerns, and develop a conception of knowledge as a virtuous process of inquiry within a genuine intellectual ethics firmly based on a Critical Commonsensist approach. [ABSTRACT FROM AUTHOR]

The writings of C. S. Peirce, the American polymath philosopher, scientist, and mathematician, are explored and investigated from a hypothetical and perhaps novel perspective. The argument pursued here is that Peirce's "economy of research" is not only of central importance to his philosophy, but that it also should be expanded to include games and the process of abduction. An abductive and game-theoretic interpretation of the economy of research creates an economically and philosophically dynamic conception of how humans create new knowledge. This broader conception of an abductive, economically constrained, and strategically embellished process of intellectual innovation may be humanity's most economic resource. Philosophically, the hypotheses provides a more expansive conception of Peirce's pragmatism, an expansion I believe he intended to make. Peirce's writings on the economy of research, abduction, and games could be of great significance for contemporary applications of Peirce's pragmatism to economics, social science, and interdisciplinary fields such as law and economics. [ABSTRACT FROM AUTHOR]

Brief introduction to four papers on the economy of research published in this issue of the Transactions. The papers were originally presented in a workshop on the economy of research at Bocconi University, October 5–6, 2017. [ABSTRACT FROM AUTHOR]

The science of the brain and nervous system cuts across almost all aspects of human life and is one of the fastest growing scientific fields worldwide. This necessitates the demand for pragmatic investment by all nations to ensure improved education and quality of research in Neurosciences. Although obvious efforts are being made in advancing the field in developed societies, there is limited data addressing the state of neuroscience in sub-Saharan Africa. Here, we review the state of neuroscience development in Nigeria, Africa’s most populous country and its largest economy, critically evaluating the history, the current situation and future projections. This review specifically addresses trends in clinical and basic neuroscience research and education. We conclude by highlighting potentially helpful strategies that will catalyse development in neuroscience education and research in Nigeria, among which are an increase in research funding, provision of tools and equipment for training and research, and upgrading of the infrastructure at hand. [ABSTRACT FROM AUTHOR]

Purpose Research suggests that 85 per cent of health research is avoidably wasted. The research and development management community has an important role in the research process and can contribute to improving the quality and value of research. Al-Shahi Salman et al. (2014) identified ways in which the community can contribute towards the reduction of research waste by increasing the efficiency of recruitment and retention of research participants, data management and data sharing in studies, and promoting the integration of research into practice. The paper aims to discuss these issues.Design/methodology/approach A project undertaken between May 2016 and May 2017 explored the perspective, and contribution, towards reducing research waste amongst the research and development management community. The study identified those categories of research waste the community felt were the most important and of the most value to address. It also examined spheres of influence and barriers to addressing research waste.Findings The most important and highest value categories of research waste to address were: implementation of research in practice, prioritisation of research, and design, conduct and analysis of research. The research and development management community’s level of influence in those areas was low. The categories where the community felt they had most influence, with the exception of design, conduct and analysis of research, were generally those they thought were less important and valuable, i.e. research taking place to time and target, public and patient involvement, and administration.Originality/value Waste in research is a significant area of waste in health care expenditure. This study has provided a better understanding of research waste for the research management community. The research and development management community can take a leadership role in formulating an action plan and identifying measures of success in reducing waste in research. [ABSTRACT FROM AUTHOR]

Background. Studies indicate that the prevalence of multidrug-resistant infections, including hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), has been rising. There are many challenges associated with these disease conditions and the ability to develop new treatments. Additionally, HABP/VABP clinical trials are very costly to conduct given their complex protocol designs and the difficulty in recruiting and retaining patients. Methods. With input from clinicians, representatives from industry, and the US Food and Drug Administration, we conducted a study to (1) evaluate the drivers of HABP/VABP phase 3 direct and indirect clinical trial costs; (2) to identify opportunities to lower these costs; and (3) to compare (1) and (2) to endocrine and oncology clinical trials. Benchmark data were gathered from proprietary and commercial databases and used to create a model that calculates the fully loaded (direct and indirect) cost of typical phase 3 HABP/VABP endocrine and oncology clinical trials. Results. Results indicate that the cost per patient for a 200-site, 1000-patient phase 3 HABP/VABP study is $89 600 per patient. The cost of screen failures and screen failure rates are the main cost drivers. Conclusions. Results indicate that biopharmaceutical companies and regulatory agencies should consider strategies to improve screening and recruitment to decrease HABP/VABP clinical trial costs. [ABSTRACT FROM AUTHOR]

Gun violence is a major cause of preventable injury and death in the United States, leading to more than 33,000 deaths each year. However, gun violence prevention is an understudied and underfunded area of research. We review the barriers to research in the field, including restrictions on federal funding. We then outline potential areas in which further research could inform clinical practice, public health efforts, and public policy. We also review examples of innovative collaborations among interdisciplinary teams working to develop strategies to integrate gun violence prevention into patient-doctor interactions in order to interrupt the cycle of gun violence. [ABSTRACT FROM AUTHOR]

Eliminating disparities in health can benefit from the inclusion of diverse populations pursuing health disparity research careers. A goal of the Texas Center for Health Disparities (TCHD) is to provide opportunities for underrepresented minority faculty to become successful health disparity researchers. The TCHD created the Steps Toward Academic Research (STAR) fellowship program to provide faculty and community partners a yearlong face-to-face and online hybrid curriculum focused on acquiring fundamental concepts in biomedical and behavioral health disparity research, basics in grantsmanship as well as professional development skills. In total, this training approach is envisioned to provide mutually beneficial co-learning experiences that will increase the number of under-represented minorities (URMs) entering translational research focused on the elimination of health disparities. [ABSTRACT FROM AUTHOR]

Objective: To categorize the research topics covered by a sample of cohort studies exploring the association between nutrition and obesity; to describe their funding sources; and to explore the association between funding sources and research topics.Design: Cross-sectional study.Subjects: Cohort studies retrieved from MEDLINE and PubMed published between 2010 and 2016.Results: One hundred and twenty-one studies were included. Funding source and conflicts of interest were disclosed in 95·0 and 90·1 % of the studies, respectively. Food industry sponsorship was disclosed in 8·3 % of the studies. Half of the studies analysed the consumption of a single food or food groups, 18·2 % included an analysis of dietary patterns and 17·4 % focused on specific nutrients. Highly processed foods were considered in 48·8 % of the studies and 27·3 % considered dietary behaviours (e.g. eating away from home). No statistically significant differences in research topics were observed between industry- and non-industry-funded studies.Conclusions: Cohort studies focused on more complex exposures (e.g. food or dietary patterns) rather than single nutrients. No significant differences in the research agenda by funding sources were observed. The analysis was limited by the low proportion of studies with disclosed food industry sponsorship. [ABSTRACT FROM AUTHOR]

Crowdfunding is an expanding form of alternative financing that is gaining traction in the health sector. This article presents a typology for crowdfunded health projects and a review of the main economic benefits and risks of crowdfunding in the health market. We use evidence from a literature review, complimented by expert interviews, to extend the fundamental principles and established theories of crowdfunding to a health market context. Crowdfunded health projects can be classified into four types according to the venture's purpose and funding method. These are projects covering health expenses, fundraising health initiatives, supporting health research, or financing commercial health innovation. Crowdfunding could economically benefit the health sector by expanding market participation, drawing money and awareness to neglected health issues, improving access to funding, and fostering project accountability and social engagement. However, the economic risks of health-related crowdfunding include inefficient priority setting, heightened financial risk, inconsistent regulatory policies, intellectual property rights concerns, and fraud. Theorized crowdfunding behaviours such as signalling and herding can be observed in the market for health-related crowdfunding. Broader threats of market failure stemming from adverse selection and moral hazard also apply. Many of the discussed economic benefits and risks of crowdfunding health campaigns are shared more broadly with those of crowdfunding projects in other sectors. Where crowdfunding health care appears to diverge from theory is the negative externality inefficient priority setting may have towards achieving broader public health goals. Therefore, the market for crowdfunding health care must be economically stable, as well as designed to optimally and equitably improve public health. [ABSTRACT FROM AUTHOR]

Background: Academic clinical trials play a fundamental role in the development of new treatments, the repurposing of existing treatments and in addressing areas of unmet clinical need. With cancer treatments increasingly targeted at molecular subtypes, and with priority placed on developing new treatments for rare tumour types, the need for international trial participation to access sufficient patient numbers for successful trial conduct is growing. However, lack of harmonisation of international legal, ethical and financial systems can make this challenging and the cost and effort of conducting trials internationally can be considered prohibitive, particularly where the sample size is comparatively small.Methods: The Institute of Cancer Research - Clinical Trials and Statistics Unit (ICR-CTSU) is a UK-based academic clinical trials unit that specialises in the design, conduct and analysis of clinical trials of cancer treatments with an expanding portfolio of trials in molecular subtypes of breast and urological cancers and in other rare cancer types. Implementing appropriate mechanisms to enable international participation has therefore been imperative. In this article, we explain how we have approached the challenges involved and describe examples of successful international trial conduct, achieved through robust collaborations with academic and industry partners.Conclusion: Conducting academic trials internationally is challenging but can and should be achieved through appropriate governance mechanisms and strong collaborations. [ABSTRACT FROM AUTHOR]

Background: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.Methods: We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.Results: The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.Conclusions: The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area. [ABSTRACT FROM AUTHOR]

The roles of income and technology as the major determinants of aggregate healthcare expenditure (HEXP) continue to interest economists and health policy researchers. Concepts and measures of medical technologies remain complex; however, income (on the demand side) and technology (on the supply side) are important drivers of HEXP. This paper presents analysis of Australia's HEXP, using time-series econometrics modeling techniques applied to 1971-2011 annual aggregate data. Our work fills two important gaps in the literature. First, we model the determinants of Australia's HEXP using the latest and longest available data series. Second, this novel study investigates several alternative technology proxies (input and output measures), including economy-wide research and development expenditures, hospital research expenditures, mortality rate, and two technology indexes based on medical devices. We then apply the residual component method and the technology proxy approach to quantify the technology effects on HEXP. Our empirical results suggest that Australian aggregate healthcare is a normal good and a technical necessity with the income elasticity estimates ranging from 0.51 to 0.97, depending on the model. The estimated technology effects on HEXP falling in the 0.30-0.35 range and mimicking those in the literature using the US data, reinforce the global spread of healthcare technology. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013.Methods: The data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis.Results: The USA, Germany, France, Canada, and United Kingdom were the "top five" countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p < 0.001) while phase 3 trials were much more prevalent in all nine representative countries than in the USA. A larger number of "child" age group trials was performed in Poland (OR 1.852, p < 0.001), Israel (OR 1.546, p = 0.005), and South Africa (OR 1.963, p < 0.001) than in the USA. Multivariate analysis showed that health care expenditure per capita, Economic Freedom Index, Human Capital Index, and Intellectual Property Rights Index could explain the variance of regional distribution of clinical trials by 63.6%.Conclusions: The globalization of clinical trials in the emerging regions of Asia, South Africa, and Eastern Europe developed in parallel with the factors of economic drive, population for recruitment, and regulatory constraints. [ABSTRACT FROM AUTHOR]

Introduction: Due to changing macro and micro factors, expiring patents and falling net income, pharmaceutical companies need to rethink their vertical business model. The trend shows cross-sectorial partnerships and consolidation to remain and compete on the market. Areas covered: Quantitative research interviewing a target group of 25 key executives from small, mid and large global pharmaceutical companies rounded with qualitative literature research completing the analysis. Expert commentary: Uncertainty in the industry due to changing external factors i.e. pricing pressures, regulations or an economic slowdown, slowing down innovations and new drug outcomes. Pharmaceutical companies understand the existing hurdles, and are critically optimistic implementing new business models. Also, various stakeholders are included in the value chain due to their growing importance.Conclusion: During the next years, the industry will be restructured from volume towards value, and only pharmaceutical companies' clairaudient and reciprocate to the changes with an out-off the box thinking will be able to resist on the market. Small biotech companies should focus on research, and big pharmaceutical companies entering at development focusing on the process until the distribution. This execution business recommendation would enable the best know-how at the right point, mitigating the risk and enhancing the patient outcomes. [ABSTRACT FROM AUTHOR]

Background: The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities.Methods: Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, and written justification for, costs associated with CTU activities required to implement an identical protocol. The protocol described a 5.5-year, nonpharmacological randomized controlled trial (RCT) conducted at 20 centres. Direct and indirect costs, the number of full time equivalents (FTEs) and the FTEs attracting overheads were compared and qualitative methods (unstructured interviews and thematic analysis) were used to interpret the results. Four members of the group (funding-body representatives or award panel members) reviewed the justification statements for transparency and information content. Separately, 163 activities common to trials were assigned to roles used by nine CTUs; the consistency of role delineation was assessed by Cohen's κ.Results: Median full economic cost of CTU activities was £769,637 (range: £661,112 to £1,383,323). Indirect costs varied considerably, accounting for between 15% and 59% (median 35%) of the full economic cost of the grant. Excluding one CTU, which used external statisticians, the total number of FTEs ranged from 2.0 to 3.0; total FTEs attracting overheads ranged from 0.3 to 2.0. Variation in directly incurred staff costs depended on whether CTUs: supported particular roles from core funding rather than grants; opted not to cost certain activities into the grant; assigned clerical or data management tasks to research or administrative staff; employed extensive on-site monitoring strategies (also the main source of variation in non-staff costs). Funders preferred written justifications of costs that described both FTEs and indicative tasks for funded roles, with itemised non-staff costs. Consistency in role delineation was fair (κ = 0.21-0.40) for statisticians/data managers and poor for other roles (κ < 0.20).Conclusions: Some variation in costs is due to factors outside the control of CTUs such as access to core funding and levels of indirect costs levied by host institutions. Research is needed on strategies to control costs appropriately, especially the implementation of risk-based monitoring strategies. [ABSTRACT FROM AUTHOR]

The different countries that death and dying researchers reside within often shape not only research agendas but also research methodologies. The United Kingdom and the United States are two examples of countries that share a common language and intellectual history but their discourses on death have been very different. These differences are partly explained through cultural practices, and also government funding of research, definitions of death and end-of-life planning education. In this article, we argue that early death scholarship in the United States impacted death research and outcomes in both the US and the UK, but that recent scholarship in both countries has caused the two countries to diverge in two major areas: (1) the methodological approaches to death studies and (2) the educational training of medical and hospice personnel in direct contact with the dying. We argue that in order for death studies to fully benefit from trans-Atlantic dialogue on death, both countries need to move towards a more integrated trans-disciplinary model. [ABSTRACT FROM PUBLISHER]

This article analyses attitudes of academic authors toward open access ( OA) and the frequency of choosing OA publication venues. The research looks particularly at differences between authors based in countries with a gross domestic product per capita less or greater than US$18,000 (called periphery and core countries, respectively). The data were obtained with an online survey sent to 107,296 scholars listed on the mailing lists belonging to De Gruyter Open from December 2015 to January 2016. A total of 1,012 responses were received. Authors from the periphery countries publish their articles in gold OA more often and they also pay OA publication fees equally often as those based in the core countries. The reasons for that are complex, involving both their preference to publish in OA and the composition of the publishing market in the periphery. [ABSTRACT FROM AUTHOR]

Background: Global healthcare innovation networks nowadays have expanded beyond developed countries with many developing countries joining the force and becoming important players. China, in particular, has seen a significant increase in the number of innovative firms and research organizations stepping up to the global network in recent years. Nevertheless, the intense Research and Development input has not brought about the expectable output. While China is ascending at a great speed to a leading position worldwide in terms of Research and Development investment, scientific publications and patents, the innovation capabilities in the pharmaceutical sector remain weak.Discussion: This study discusses the challenges and opportunities for pharmaceutical innovation in China. One hand, academic, industrial, institutional and financial constraints were found to be the major and inevitable barriers hindering the development of drug innovation. On the other hand, unique advantages had been observed which included growing pharmaceutical market, Research and Development funding, distinctive source, and international cooperation. The most important thing for China's pharmaceutical sector to leap forward is to break though innovation barriers and integrate own advantages into global value-chain of healthcare product development. [ABSTRACT FROM AUTHOR]

An essential, but often overlooked part of health promotion and development support to achieve self-sufficiency in developing countries is the concomitant need to build and strengthen research capacity. This is even more challenging and critical in the area of sexual and reproductive health because of diverse interplay of socio cultural, religious, economic factors in relation to reproductive health. This paper presents the case study of HRP's efforts to build research capacity in Latin America by studying and analyzing the 5-year history of institutional development support to an institution in Paraguay. In reviewing the efforts, we identify the strengths in the approaches used by HRP, the challenges and outcomes of the process and we present recommendations for future efforts to strengthen research capacity to improve sexual and reproductive health. The authors call for greater support from and collaborative efforts of developmental partners and governments to strengthen research capacity in low and middle-income countries to improve sexual and reproductive health. [ABSTRACT FROM AUTHOR]

Background Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT). Methods We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. Results We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88–6·83], p < 0001), intention-to-treat analysis (RR 1·32, 95% CI [1·04–1·67], p = 02), and blinding of patients (RR 3·05, 95% CI [1·71–5·44], p < 0001), clinicians (RR 3·36, 95% CI [1·83–6·16], p≤·001) and outcomes assessors (RR 3·03, 95% CI [1·57–5·83], p = 0002). They did not differ in use of overall survival as a primary end-point (RR 1·27 95% CI [0·72–2·24]) and were similarly likely to report positive results (RR 1·11 95% CI [0·85–1·46], p = 0.45). Studies with funding only did not differ from those without funding. Conclusions Oncology RCTs with industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias. [ABSTRACT FROM AUTHOR]

This paper discusses an approach allowing researchers – users of some CRIS – to initiate and maintain scholarly pre-publication communication. The pre-publication communication takes place between authors of some research outputs and researchers who use these outputs on a stage of preparing their own research papers. Such communication is initiated when a researcher who uses CRIS tools is manipulating with a research output text and/or with the text fragments to create his/her own research outputs. In this paper a SocioRePEc CRIS is presented, which is being designed specifically to allow researchers in economics (who belong to a bigger international community of RePEc users) to make experiments with the pre-publication communication. By this, researchers get capacity to use research outputs available at RePEc (metadata and/or full texts in PDF) in so-called “interactive” mode. The discussion explains that this interactive usage mode leads to better adjustment of the researchers’ supply and demand, and opens an opportunity for the further wider/deeper research cooperation. [ABSTRACT FROM AUTHOR]

As in many other countries, the scholarly Open Access movement has been gaining momentum in Finland in recent years. There is a growing political pressure for taking steps towards more comprehensive Open Access availability of Finnish research publications. One of the ideas currently under discussion is whether it would be possible to use Open Access availability of research publications as a factor in the funding model for the Finnish universities. However, a key challenge is that at the moment there is no reliable, comprehensive data on how much of the Finnish research output actually is freely available. This paper discusses some of the plans on how to address this situation on a national level. The discussion may provide useful insights for other countries facing similar questions. [ABSTRACT FROM AUTHOR]

Researchers investigating phenomena in nursing education are increasingly striving to conduct multisite studies. However, designing and managing multisite studies can be costly and time consuming. One complex and costly challenge of multisite studies can be anticipating and navigating the variations in the institutional review board requirements and expectations of different study sites. This article explores issues and regulations around protection of human subjects in multisite studies using the authors' experiences launching the 2016 National Nursing Education Research Network surveys as an exemplar. [ABSTRACT FROM AUTHOR]

Increasing political and financial support for scientific research in the Middle East requires academic and research communities in the region to demonstrate the visibility and impact of their scientific output. However, for countries with smaller scientific communities or lack of detailed information on their scientific production, the use of common metrics of scientific impact (e.g., number of papers, impact factor, h-index, etc.) may fail to reveal their true ability to produce high quality research, and thus guarantee the wanted societal support. In such cases, identifying and highlighting outstanding papers produced by national institutions or scientists may be another way to demonstrate scientific capacity and impact. In this context, this work aims to provide an overview of champion works (papers that have received over 1,000 citations) produced by Middle East countries. This analysis focuses on science, medicine, and technology papers featured in the Science Citation Index Expanded of Web of Science. The authors identified 213 champion works authored by Middle East scientists published since the 1970s. Israel is currently the leading nation in the Middle East in terms of published champion works, but at least one such work was identified for the majority of countries in the region. Middle East champion works were published on a diverse range of subject categories and often featured in the top journals worldwide (e.g., Science, Nature, etc.). The top institutions in the Middle East authoring champion works and their leading collaborating countries worldwide are listed, and the role of international scientific collaborations in achieving these highly cited papers is highlighted. [ABSTRACT FROM PUBLISHER]

We present a model combining the two regulatory stages relevant to the approval of a new health technology: the authorisation of its commercialisation and the insurer's decision about whether to reimburse its cost. We show that the degree of uncertainty concerning the true value of the insurer's maximum willingness to pay for a unit increase in effectiveness has a non-monotonic impact on the optimal price of the innovation, the firm's expected profit and the optimal sample size of the clinical trial. A key result is that there exists a range of values of the uncertainty parameter over which a reduction in uncertainty benefits the firm, the insurer and patients. We consider how different policy parameters may be used as incentive mechanisms, and the incentives to invest in R&D for marginal projects such as those targeting rare diseases. The model is calibrated using data on a new treatment for cystic fibrosis. [ABSTRACT FROM AUTHOR]

The article presents a speech by Yifeng Wu, professor of the School of Economics, Renmin University of China, delivered at the World Marxian Economics Award ceremony, held on June 17, 2016. Topics of the speech included study of the origin of Marxist economic theories, study of representative works of Marxist economic theories and their sinicization, and studies of western economics and criticism of neoliberalism.

Aims To provide an overview of gambling and problem gambling in Switzerland, including historical aspects, past and current legislation and policies, treatment options and the research base. Methods A literature search was conducted on two databases (PubMed and PsycINFO), and official government and statistical reports selected from the official websites of four sources (Federal Office of Justice; Federal Gambling Board; Federal Office of Statistics; Swiss Lottery and Betting Board). Results After a history of banning or partial banning, Swiss gambling became regulated at the beginning of the 20th century through successive laws. The current system is characterized by important differences in the law and policies for casinos and lotteries, and contradictions in the regulation of these two areas are still under debate in order to develop new legislation. Gambling is widespread in Switzerland, and the prevalence of problem gambling in this country was comparable to that in other European countries in 2014. Most gambling treatment facilities are integrated into mental health treatment services that have out-patient programmes, and treatment for problem gambling is covered by a universal compulsory Swiss health insurance system. The availability of public funding for gambling research is still limited. Conclusions Switzerland needs to develop a more coherent regulatory and prevention policy approach to gambling, overcoming conflicts in the current dual system of federal and cantonal regulation. Recent efforts to enhance funding for gambling research are promising, and could lead to a more systematic analysis of the efficacy of prevention and treatment programmes. [ABSTRACT FROM AUTHOR]

Importance: The increasing cost of prescription drugs in the United States has become a source of concern for patients, prescribers, payers, and policy makers.Objectives: To review the origins and effects of high drug prices in the US market and to consider policy options that could contain the cost of prescription drugs.Evidence: We reviewed the peer-reviewed medical and health policy literature from January 2005 to July 2016 for articles addressing the sources of drug prices in the United States, the justifications and consequences of high prices, and possible solutions.Findings: Per capita prescription drug spending in the United States exceeds that in all other countries, largely driven by brand-name drug prices that have been increasing in recent years at rates far beyond the consumer price index. In 2013, per capita spending on prescription drugs was $858 compared with an average of $400 for 19 other industrialized nations. In the United States, prescription medications now comprise an estimated 17% of overall personal health care services. The most important factor that allows manufacturers to set high drug prices is market exclusivity, protected by monopoly rights awarded upon Food and Drug Administration approval and by patents. The availability of generic drugs after this exclusivity period is the main means of reducing prices in the United States, but access to them may be delayed by numerous business and legal strategies. The primary counterweight against excessive pricing during market exclusivity is the negotiating power of the payer, which is currently constrained by several factors, including the requirement that most government drug payment plans cover nearly all products. Another key contributor to drug spending is physician prescribing choices when comparable alternatives are available at different costs. Although prices are often justified by the high cost of drug development, there is no evidence of an association between research and development costs and prices; rather, prescription drugs are priced in the United States primarily on the basis of what the market will bear.Conclusions and Relevance: High drug prices are the result of the approach the United States has taken to granting government-protected monopolies to drug manufacturers, combined with coverage requirements imposed on government-funded drug benefits. The most realistic short-term strategies to address high prices include enforcing more stringent requirements for the award and extension of exclusivity rights; enhancing competition by ensuring timely generic drug availability; providing greater opportunities for meaningful price negotiation by governmental payers; generating more evidence about comparative cost-effectiveness of therapeutic alternatives; and more effectively educating patients, prescribers, payers, and policy makers about these choices. [ABSTRACT FROM AUTHOR]

Purpose – The purpose of this paper is to examine the causal relationship between research publications and economic growth – using time-series data from South Africa. The paper attempts to answer two critical questions: is there a long-run relationship between research publications and economic growth in South Africa? Do research publications from South African researchers Granger-cause economic growth? Design/methodology/approach – Unlike some of the previous studies, the current paper uses a trivariate ECM-based Granger-causality model to examine this linkage. Specifically, the study incorporates education as an intermittent variable between research and economic growth. In addition, the paper uses the recently developed autoregressive distributed lag (ARDL)-bounds testing procedure, which has numerous advantages, especially when the sample size is small. Findings – The results of this study show that there is a long-run relationship between research publications and economic growth in South Africa. The results also show that there is a distinct causal flow from research publications to economic growth in South Africa. This applies both in the short-run and in the long-run. Other results also show that: there is a short-run bidirectional causality between research publications and education; and there is a short-run bi-directional causality between education and economic growth, but a long-run unidirectional causal flow from education to economic growth. Practical implications – The findings of this paper underscore the crucial role that research plays in economic growth and development. Overall, the findings of this study show that research in South Africa is pro-growth. This implies that the recent significant increase in government expenditure on research and innovation, which is aimed at increasing the country’s scientific research outputs, is likely to pay off. Originality/value – To the best of the authors’ knowledge, this paper is the first of its kind to examine in detail the dynamic causal relationship between research outputs and economic growth in South Africa – using the recently developed ARDL-bounds testing approach within a trivariate setting. [ABSTRACT FROM AUTHOR]

The article reports on the use of Child Health and Nutrition Research Initiative (CHNRI) method to set transparent and inclusive health research priorities, involving researchers.