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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]

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]

The article discusses grantsmanship, or the process of writing grant proposal, and examines its importance within library science. Noted reasons for librarians to submit grant proposals include advancement of knowledge, economic development through research, and career development. Particular attention is given to the specific aspects of a grant proposal, such as the narrative, budget justification, and sustainability plan.

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

A serious need to spur antibiotic innovation has arisen because of the lack of antibiotics to combat certain conditions and the overuse of other antibiotics leading to greater antibiotic resistance. In response to this need, proposals have been made to Congress to fund antibiotic research through a voucher program for new antibiotics, which would delay generic entry for any drug, even potential blockbuster lifesaving generics. We find this proposal to be inefficient, in part because of the mismatch between the private value of the voucher and the public value of the antibiotic innovation. However, vouchers have the political advantage in the United States of being able to raise sufficient amounts of money without annual appropriations from Congress. We propose that if antibiotic vouchers are to be considered, the design should include dollar and time caps to limit their volatility, sufficient advance notice to protect generic manufacturers, and market-based linkages between the value of the voucher and the value of the antibiotic innovation. We also explore a second option: The federal government could auction vouchers to the highest bidders and use the money to create an antibiotics innovation fund. [ABSTRACT FROM AUTHOR]

Each of the thousands of rare neurological diseases requires a widely distributed network of centres, investigators and patients, so as to foster multidisciplinary investigations and involve sufficient numbers of patients in the discovery of disease pathogenesis and novel treatment. In this Review, we highlight the value of this collaborative approach in patient-oriented research into rare neurological channelopathies. Two networks, the Consortium for Clinical Investigations of Neurological Channelopathies (CINCH) and the Clinical Research Consortium for Studies of Cerebellar Ataxias (CRC-SCA), provide a link between patients with rare channelopathies and investigators who are studying disease pathogenesis and developing novel treatments. Interactions between patients, researchers and advocacy groups promote shared agendas that benefit patient education and recruitment, research collaboration and funding, and training and mentoring of junior investigators who are attracted to the study of the diseases that provide the focus for the two networks. Here, we discuss how linkage of national and international centres has enabled recruitment of study participants, provided opportunities for novel studies of pathogenesis, and facilitated successful clinical trials. [ABSTRACT FROM AUTHOR]

Africa is a continent characterized by marked ethnic, sociodemographic, and economic diversity, with profound changes in many regions over the past 2 decades. This diversity has an impact on cardiovascular disease presentation and outcomes. Within Africa and within the individual countries, one can find regions having predominantly communicable diseases such as rheumatic heart disease, tuberculous pericarditis, or cardiomyopathy and others having a marked increase in noncommunicable disease such as hypertension and hypertensive heart disease. Ischemic heart disease remains rare in most countries. Difficulties in the planning and implementation of effective health care in most African countries are compounded by a paucity of studies and a low rate of investment in research and data acquisition. The fiduciary responsibilities of companies working in Africa should include the effective and efficient use of natural resources to promote the overall health of populations. [ABSTRACT FROM AUTHOR]

The article discusses the legal aspects of biobanking and a right to privacy in India, and it mentions the globalization of science and technology, as well as India's regulation and governance of biomedical research. Emerging technologies are addressed, along with ethical conflicts involving research and development (R&D) and clinical trials. Millennium Development Goals (MDGs) are examined, along with the Indian Council for Medical Research and health research, and non-communicable diseases.

The article discusses the relationships between privacy and biobanking laws in the Federal Republic of Germany (Germany) as of 2016, and it mentions the German health and biomedical research systems, as well as the doctrine of informational self determination and judgments issued by the German Constitutional Court. German constitutional rights are assessed, as well as human rights and Germany's parliamentary democracy form of government. Germany's Biobank Act is also examined.

Background: Government- and charity-funded medical research and private sector research and development (R&D) are widely held to be complements. The only attempts to measure this complementarity so far have used data from the United States of America and are inevitably increasingly out of date. This study estimates the magnitude of the effect of government and charity biomedical and health research expenditure in the United Kingdom (UK), separately and in total, on subsequent private pharmaceutical sector R&D expenditure in the UK.Methods: The results for this study are obtained by fitting an econometric vector error correction model (VECM) to time series for biomedical and health R&D expenditure in the UK for ten disease areas (including 'other') for the government, charity and private sectors. The VECM model describes the relationship between public (i.e. government and charities combined) sector expenditure, private sector expenditure and global pharmaceutical sales as a combination of a long-term equilibrium and short-term movements.Results: There is a statistically significant complementary relationship between public biomedical and health research expenditure and private pharmaceutical R&D expenditure. A 1% increase in public sector expenditure is associated in the best-fit model with a 0.81% increase in private sector expenditure. Sensitivity analysis produces a similar and statistically significant result with a slightly smaller positive elasticity of 0.68. Overall, every additional £1 of public research expenditure is associated with an additional £0.83-£1.07 of private sector R&D spend in the UK; 44% of that additional private sector expenditure occurs within 1 year, with the remainder accumulating over decades. This spillover effect implies a real annual rate of return (in terms of economic impact) to public biomedical and health research in the UK of 15-18%. When combined with previous estimates of the health gain that results from public medical research in cancer and cardiovascular disease, the total rate of return would be around 24-28%.Conclusion: Overall, this suggests that government and charity funded research in the UK crowds in additional private sector R&D in the UK. The implied historical returns from UK government and charity funded investment in medical research in the UK compare favourably with the rates of return achieved on investments in the rest of the UK economy and are greatly in excess of the 3.5% real annual rate of return required by the UK government to public investments generally. [ABSTRACT FROM AUTHOR]

Background: The extent to which trial-level factors differentially influence accrual to trials has not been comprehensively studied. Our objective was to evaluate the empirical relationship and predictive properties of putative risk factors for low accrual in the National Cancer Institute's (NCI's) Cooperative Group Program, now the National Clinical Trials Network (NCTN).Methods: Data from 787 phase II/III adult NCTN-sponsored trials launched between 2000 and 2011 were used to develop a logistic regression model to predict low accrual, defined as trials that closed with or were accruing at less than 50% of target; 46 trials opened between 2012 and 2013 were used for prospective validation. Candidate predictors were identified from a literature review and expert interviews; final predictors were selected using stepwise regression. Model performance was evaluated by calibration and discrimination via the area under the curve (AUC). All statistical tests were two-sided.Results: Eighteen percent (n = 145) of NCTN-sponsored trials closed with low accrual or were accruing at less than 50% of target three years or more after initiation. A multivariable model of twelve trial-level risk factors had good calibration and discrimination for predicting trials with low accrual (AUC in trials launched 2000-2011 = 0.739, 95% confidence interval [CI] = 0.696 to 0.783]; 2012-2013: AUC = 0.732, 95% CI = 0.547 to 0.917). Results were robust to different definitions of low accrual and predictor selection strategies.Conclusions: We identified multiple characteristics of NCTN-sponsored trials associated with low accrual, several of which have not been previously empirically described, and developed a prediction model that can provide a useful estimate of accrual risk based on these factors. Future work should assess the role of such prediction tools in trial design and prioritization decisions. [ABSTRACT FROM AUTHOR]

Objective. Migrants constitute 26% of the total Australian population and, although disproportionately affected by chronic diseases, they are under-represented in health research. The aim of the present study was to describe trends in Australian Research Council (ARC)- and National Health and Medical Research Council (NHMRC)-funded initiatives from 2002 to 2011 with a key focus on migration-related research funding. Methods. Data on all NHMRC- and ARC-funded initiatives between 2002 and 2011 were collected from the research funding statistics and national competitive grants program data systems, respectively. The research funding expenditures within these two schemes were categorised into two major groups: (1) people focused (migrant-related and mainstreamrelated); and (2) basic science focused. Descriptive statistics were used to summarise the data and report the trends inNHMRC and ARC funding over the 10-year period. Results. Over 10 years, the ARC funded 15 354 initiatives worth A$5.5 billion, with 897 (5.8%) people-focused projects funded, worth A$254.4 million. Migrant-related research constituted 7.8% of all people-focused research. The NHMRC funded 12 399 initiatives worth A$5.6 billion, with 447 (3.6%) people-focused projects funded, worth A$207.2 million. Migrant-related research accounted for 6.2% of all people-focused initiatives. Conclusions. Although migrant groups are disproportionately affected by social and health inequalities, the findings of the present study show that migrant-related research is inadequately funded compared with mainstream-related research. Unless equitable research funding is achieved, it will be impossible to build a strong evidence base for planning effective measures to reduce these inequalities among migrants. [ABSTRACT FROM AUTHOR]

The article discusses research on waiving parental consent for adolescent research. It aims to obtain institutional review board approval of waiver 45 C.F.R. S 46.116 of the U.S. Department of Health and Human Services Code of Federal Regulations. It states that the waiver decrease research costs, reduce participation selection bias, and expand data availability especially on health issues like nonmedical prescription drug (NMPDU) use among them.

Objective: To investigate a novel methodology, which was cost effective, to collect large amounts of data to further understand medication purchases and misuse in rural India. Background: In India it is estimated that one third of expenditure of households is spent on health related expenses, and medication purchases make up a large proportion of these costs. Methods: This study explores the research approach that was conducted in 2012-13 by Layleaders enrolled in the Community Lay-Leaders' Health Certificate Program initiative by Christian Medical College (CMC), Vellore, India. Results: The methodology demonstrated a large data collection capacity, where 100 Layleaders participated and collected over 5000 surveys across 515 villages in North, Central and North East India Conclusions: Incorporating opportunistic research methods into community health worker training can be a cost effective way to collect meaningful and useful data in rural India. This study demonstrates a successful methodology that may be transferable to other rural areas and others conducting research training as part of community health worker training should consider such opportunistic research [ABSTRACT FROM AUTHOR]

The article presents the study on the expectations of citizens on the academic entrepreneurship (AE), an academic nature of commercial science, and the analysis of the conflict of interest (COI), practical benefits, and general beliefs. A cross-sectional survey was designed to assess the approval of AE varying on the type of concerns. Results were outlined and conclude the support of citizens on AE considering their expectation on the benefits of academic-industry collaboration.