FAIR, ethical, and coordinated data sharing for COVID-19 response: a scoping review and cross-sectional survey of COVID-19 data sharing platforms and registries.

Data sharing is central to the rapid translation of research into advances in clinical medicine and public health practice. In the context of COVID-19, there has been a rush to share data marked by an explosion of population-specific and discipline-specific resources for collecting, curating, and disseminating participant-level data. We conducted a scoping review and cross-sectional survey to identify and describe COVID-19-related platforms and registries that harmonise and share participant-level clinical, omics (eg, genomic and metabolomic data), imaging data, and metadata. We assess how these initiatives map to the best practices for the ethical and equitable management of data and the findable, accessible, interoperable, and reusable (FAIR) principles for data resources. We review gaps and redundancies in COVID-19 data-sharing efforts and provide recommendations to build on existing synergies that align with frameworks for effective and equitable data reuse. We identified 44 COVID-19-related registries and 20 platforms from the scoping review. Data-sharing resources were concentrated in high-income countries and siloed by comorbidity, body system, and data type. Resources for harmonising and sharing clinical data were less likely to implement FAIR principles than those sharing omics or imaging data. Our findings are that more data sharing does not equate to better data sharing, and the semantic and technical interoperability of platforms and registries harmonising and sharing COVID-19-related participant-level data needs to improve to facilitate the global collaboration required to address the COVID-19 crisis.

Improvement in Infection Prevention and Control Compliance at the Three Tertiary Hospitals of Sierra Leone following an Operational Research Study.

Implementing infection prevention and control (IPC) programmes in line with the World Health Organization's (WHO) eight core components has been challenging in Sierra Leone. In 2021, a baseline study found that IPC compliance in three tertiary hospitals was sub-optimal. We aimed to measure the change in IPC compliance and describe recommended actions at these hospitals in 2023. This was a 'before and after' observational study using two routine cross-sectional assessments of IPC compliance using the WHO IPC Assessment Framework tool. IPC compliance was graded as inadequate (0-200), basic (201-400), intermediate (401-600), and advanced (601-800). The overall compliance scores for each hospital showed an improvement from 'Basic' in 2021 to 'Intermediate' in 2023, with a percentage increase in scores of 16.9%, 18.7%, and 26.9% in these hospitals. There was improved compliance in all core components, with the majority in the 'Intermediate' level for each hospital IPC programme. Recommended actions including the training of healthcare workers and revision of IPC guidelines were undertaken, but a dedicated IPC budget and healthcare-associated infection surveillance remained as gaps in 2023. Operational research is valuable in monitoring and improving IPC programme implementation. To reach the 'Advanced' level, these hospitals should establish a dedicated IPC budget and develop long-term implementation plans.

Improving anthelmintic treatment for schistosomiasis and soil-transmitted helminthiases through sharing and reuse of individual participant data.

The Infectious Diseases Data Observatory (IDDO, https://www.iddo.org) has launched a clinical data platform for the collation, curation, standardisation and reuse of individual participant data (IPD) on treatments for two of the most globally important neglected tropical diseases (NTDs), schistosomiasis (SCH) and soil-transmitted helminthiases (STHs). This initiative aims to harness the power of data-sharing by facilitating collaborative joint analyses of pooled datasets to generate robust evidence on the efficacy and safety of anthelminthic treatment regimens. A crucial component of this endeavour has been the development of a Research Agenda to promote engagement with the SCH and STH research and disease control communities by highlighting key questions that could be tackled using data shared through the IDDO platform. Here, we give a contextual overview of the priority research themes articulated in the Research Agenda-a 'living' document hosted on the IDDO website-and describe the three-stage consultation process behind its development. We also discuss the sustainability and future directions of the platform, emphasising throughout the power and promise of ethical and equitable sharing and reuse of clinical data to support the elimination of NTDs.

Promotion of data sharing needs more than an emergency: An analysis of trends across clinical trials registered on the International Clinical Trials Registry Platform.

BACKGROUND: A growing body of evidence shows that sharing health research data with other researchers for secondary analyses can contribute to better health. This is especially important in the context of a public health emergency when stopping a pandemic depends on accelerating science. METHODS: We analysed the information on data sharing collected by the 18 clinical trial registries included in the WHO International Clinical Trials Registry Platform (ICTRP) to understand the reporting of data sharing plans and which studies were and were not planning to share data. Data on sponsor and funder organisations, country of recruitment, registry, and condition of study were standardised to compare the sharing of information and data across these facets. This represents the first ever comprehensive study of the complete data set contained in ICTRP. RESULTS: Across 132,545 studies registered between January 2019 and December 2020, 11.2% of studies stated that individual patient data (IPD) would be shared. Plans to share IPD varied across the 18 contributing registries- information on data sharing was missing in >95% of study records across 7/18 registries. In the 26,851 (20.3%) studies that were funded or sponsored by a commercial entity, intention to share IPD was similar to those that were not (11.5% vs 11.2%). Intention to share IPD was most common in studies recruiting across both high-income and low- or middle-income countries (21.4%) and in those recruiting in Sub-Saharan Africa (50.3%). Studies of COVID-19 had similar levels of data sharing to studies of other non-pandemic diseases in 2020 (13.7% vs 11.7%). CONCLUSIONS: Rates of planned IPD sharing vary between clinical trial registries and economic regions, and are similar whether commercial or non-commercial agencies are involved. Despite many calls to action, plans to share IPD have not increased significantly and remain below 14% for diseases causing public health emergencies.

Assessing the impact of knowledge communication and dissemination strategies targeted at health policy-makers and managers: an overview of systematic reviews.

BACKGROUND: The use of research evidence as an input for health decision-making is a need for most health systems. There are a number of approaches for promoting evidence use at different levels of the health system, but knowledge of their effectiveness is still scarce. The objective of this overview was to evaluate the effectiveness of knowledge communication and dissemination interventions, strategies or approaches targeting policy-makers and health managers. METHODS: This overview of systematic reviews used systematic review methods and was conducted according to a predefined and published protocol. A comprehensive electronic search of 13 databases and a manual search in four websites were conducted. Both published and unpublished reviews in English, Spanish or Portuguese were included. A narrative synthesis was undertaken, and effectiveness statements were developed, informed by the evidence identified. RESULTS: We included 27 systematic reviews. Three studies included only a communication strategy, while eight only included dissemination strategies, and the remaining 16 included both. None of the selected reviews provided "sufficient evidence" for any of the strategies, while four provided some evidence for three communication and four dissemination strategies. Regarding communication strategies, the use of tailored and targeted messages seemed to successfully lead to changes in the decision-making practices of the target audience. Regarding dissemination strategies, interventions that aimed at improving only the reach of evidence did not have an impact on its use in decisions, while interventions aimed at enhancing users' ability to use and apply evidence had a positive effect on decision-making processes. Multifaceted dissemination strategies also demonstrated the potential for changing knowledge about evidence but not its implementation in decision-making. CONCLUSIONS: There is limited evidence regarding the effectiveness of interventions targeting health managers and policy-makers, as well as the mechanisms required for achieving impact. More studies are needed that are informed by theoretical frameworks or specific tools and using robust methods, standardized outcome measures and clear descriptions of the interventions. We found that passive communication increased access to evidence but had no effect on uptake. Some evidence indicated that the use of targeted messages, knowledge-brokering and user training was effective in promoting evidence use by managers and policy-makers.

Assessing the impact of knowledge communication and dissemination strategies targeted at health policy-makers and managers: an overview of systematic reviews

The use of research evidence as an input for health decision-making is a need for most health systems. There are a number of approaches for promoting evidence use at different levels of the health system, but knowledge of their effectiveness is still scarce. The objective of this overview was to evaluate the effectiveness of knowledge communication and dissemination interventions, strategies or approaches targeting policy-makers and health managers.

Sharing health research data - the role of funders in improving the impact.

Recent public health emergencies with outbreaks of influenza, Ebola and Zika revealed that the mechanisms for sharing research data are neither being used, or adequate for the purpose, particularly where data needs to be shared rapidly. A review of research papers, including completed clinical trials related to priority pathogens, found only 31% (98 out of 319 published papers, excluding case studies) provided access to all the data underlying the paper - 65% of these papers give no information on how to find or access the data. Only two clinical trials out of 58 on interventions for WHO priority pathogens provided any link in their registry entry to the background data. Interviews with researchers revealed a reluctance to share data included a lack of confidence in the utility of the data; an absence of academic-incentives for rapid dissemination that prevents subsequent publication and a disconnect between those who are collecting the data and those who wish to use it quickly.  The role of the funders of research needs to change to address this. Funders need to engage early with the researchers and related stakeholders to understand their concerns and work harder to define the more explicitly the benefits to all stakeholders.  Secondly, there needs to be a direct benefit to sharing data that is directly relevant to those people that collect and curate the data. Thirdly more work needs to be done to realise the intent of making data sharing resources more equitable, ethical and efficient.  Finally, a checklist of the issues that need to be addressed when designing new or revising existing data sharing resources should be created. This checklist would highlight the technical, cultural and ethical issues that need to be considered and point to examples of emerging good practice that can be used to address them.

Developing new health technologies for neglected diseases: a pipeline portfolio review and cost model.

Background: Funding for neglected disease product development fell from 2009-2015, other than a brief injection of Ebola funding. One impediment to mobilizing resources is a lack of information on product candidates, the estimated costs to move them through the pipeline, and the likelihood of specific launches. This study aimed to help fill these information gaps. Methods: We conducted a pipeline portfolio review to identify current candidates for 35 neglected diseases. Using an adapted version of the Portfolio to Impact financial modelling tool, we estimated the costs to move these candidates through the pipeline over the next decade and the likely launches. Since the current pipeline is unlikely to yield several critical products, we estimated the costs to develop a set of priority "missing" products. Results: We found 685 neglected disease product candidates as of August 31, 2017; 538 candidates met inclusion criteria for input into the model. It would cost about $16.3 billion (range $13.4-19.8B) to move these candidates through the pipeline, with three-quarters of the costs incurred in the first 5 years, resulting in about 128 (89-160) expected product launches.  Based on the current pipeline, there would be few launches of complex new chemical entities; launches of highly efficacious HIV, tuberculosis, or malaria vaccines would be unlikely. Estimated additional costs to launch one of each of 18 key missing products are $13.6B assuming lowest product complexity or $21.8B assuming highest complexity ($8.1B-36.6B). Over the next 5 years, total estimated costs to move current candidates through the pipeline and develop these 18 missing products would be around $4.5B (low complexity missing products) or $5.8B/year (high complexity missing products). Conclusions: Since current annual global spending on product development is about $3B, this study suggests the annual funding gap over the next 5 years is at least $1.5-2.8B.

Funding global health product R&D: the Portfolio-To-Impact Model (P2I), a new tool for modelling the impact of different research portfolios.

Background: The Portfolio-To-Impact (P2I) Model is a novel tool, developed to estimate minimum funding needs to accelerate health product development from late stage preclinical study to phase III clinical trials, and to visualize potential product launches over time. Methods: A mixed methods approach was used. Assumptions on development costs at each phase were based on clinical trial costs from Parexel's R&D cost sourcebook. These were further refined and validated by interviews, with a wide variety of stakeholders from Product Development Partnerships, biopharmaceutical and diagnostic companies, and major funders of global health R&D. Results: the tool was used to create scenarios describing the impact, in terms of products developed, of different product portfolios with funding ranging from $1 million per annum through to $500 million per annum. These scenarios for a new global financing mechanism have been previously presented in a report setting out the potential for a new fund for research and development which would assist in accelerating product development for the diseases of poverty.  Conclusion: The P2I tool does enable a user to model different scenarios in terms of cost and number of health products launched when applied to a portfolio of health products.  The model is published as open access accompanied with a user guide.  The design allows it to be adapted and used for other health R&D portfolio analysis as described in an accompanying publication focussing on the pipeline for neglected diseases in 2017. We aim to continually refine and improve the model and we ask users to provide us with their own inputs that can help us update key parameters and assumptions.  We hope to catalyse users to adapt the model in ways that can increase its value, accuracy, and applications.

Global trends in health research and development expenditures--the challenge of making reliable estimates for international comparison.

Better estimates of changes in the level and structure of national, regional, and global expenditures on health research and development (R&D) are needed as an important source of information for advancing countries' health research policies. However, such estimates are difficult to compile and comparison between countries needs careful calibration. We outline the steps that need to be taken to make reliable estimates of trends in countries' expenditures on health R&D, describe that an ideal approach would involve the use of international sets of deflators and exchange rates that are specific to health R&D activities, and explain which methods should be used given the current absence of such health R&D-specific deflators and exchange rates. Finally, we describe what should be the way forward in improving our ability to make reliable estimates of trends in countries' health R&D expenditures.

Creating a global observatory for health R&D.

A global map of health R&D activity would improve the coordination of research and help to match limited resources with public health priorities, such as combating antimicrobial resistance. The challenges of R&D mapping are large because there are few standards for research classification and governance and limited capacity to report on R&D data, especially in low-income countries. Nevertheless, based on developments in semantic classification, and with better reporting of funded research though the Internet, it is now becoming feasible to create a global observatory for health R&D.

Comparison of national health research priority-setting methods and characteristics in Latin America and the Caribbean, 2002-2012.

OBJECTIVE: To compare health research priority-setting methods and characteristics among countries in Latin America and the Caribbean during 2002 - 2012. METHODS: This was a systematic review that identified national health research policies and priority agendas through a search of ministry and government databases related to health care institutions. PubMed, LILACS, the Health Research Web, and others were searched for the period from January 2002 - February 2012. The study excluded research organized by governmental institutions and specific national strategies on particular disease areas. Priority-setting methods were compared to the "nine common themes for good practice in health research priorities." National health research priorities were compared to those of the World Health Organization's Millennium Development Goals (MDG). RESULTS: Of the 18 Latin American countries assessed, 13 had documents that established national health research priorities; plus the Caribbean Health Research Council had a research agenda for its 19 constituents. These 14 total reports varied widely in terms of objectives, content, dissemination, and implementation; most provided a list of strategic areas, suggestions, and/or sub-priorities for each country; however, few proposed specific research topics and questions. CONCLUSIONS: Future reports could be improved by including more details on the comprehensive approach employed to identify priorities, on the information gathering process, and on practices to be undertaken after priorities are set. There is a need for improving the quality of the methodologies utilized and coordinating Regional efforts as countries strive to meet the MDG.

Use of data from registered clinical trials to identify gaps in health research and development.

OBJECTIVE: To explore what can be learnt about the current composition of the "global landscape" of health research and development (R&D) from data on the World Health Organization's International Clinical Trials Registry Platform (ICTRP). METHODS: A random 5% sample of the records of clinical trials that were registered as interventional and actively recruiting was taken from the ICTRP database. FINDINGS: Overall, 2381 records of trials were investigated. Analysis of these records indicated that, for every million disability-adjusted life years (DALYs) caused by communicable, maternal, perinatal and nutritional conditions, by noncommunicable diseases, or by injuries, the ICTRP database contained an estimated 7.4, 52.4 and 6.0 trials in which these causes of burden of disease were being investigated, respectively. For every million DALYs in high-income, upper-middle-income, lower-middle-income and low-income countries, an estimated 292.7, 13.4, 3.0 and 0.8 registered trials, respectively, were recruiting in such countries. CONCLUSION: The ICTRP constitutes a valuable resource for assessing the global distribution of clinical trials and for informing policy development for health R&D. Populations in lower-income countries receive much less attention, in terms of clinical trial research, than populations in higher-income countries.

Comparison of national health research priority-setting methods and characteristics in Latin America and the Caribbean, 2002 - 2012 / Comparación de los métodos de establecimiento de prioridades de investigación nacional de salud y sus características en América Latina y el Caribe, 2002 al 2012

OBJECTIVE: To compare health research priority-setting methods and characteristics among countries in Latin America and the Caribbean during 2002 - 2012. METHODS: This was a systematic review that identified national health research policies and priority agendas through a search of ministry and government databases related to health care institutions. PubMed, LILACS, the Health Research Web, and others were searched for the period from January 2002 - February 2012. The study excluded research organized by governmental institutions and specific national strategies on particular disease areas. Priority-setting methods were compared to the "nine common themes for good practice in health research priorities." National health research priorities were compared to those of the World Health Organization's Millennium Development Goals (MDG). RESULTS: Of the 18 Latin American countries assessed, 13 had documents that established national health research priorities; plus the Caribbean Health Research Council had a research agenda for its 19 constituents. These 14 total reports varied widely in terms of objectives, content, dissemination, and implementation; most provided a list of strategic areas, suggestions, and/or sub-priorities for each country; however, few proposed specific research topics and questions. CONCLUSIONS: Future reports could be improved by including more details on the comprehensive approach employed to identify priorities, on the information gathering process, and on practices to be undertaken after priorities are set. There is a need for improving the quality of the methodologies utilized and coordinating Regional efforts as countries strive to meet the MDG.

OBJETIVO: Comparar los métodos de establecimiento de prioridades de investigación de salud y sus características en los países de América Latina y el Caribe durante el período del 2002 al 2012. MÉTODOS: Se llevó a cabo una revisión sistemática que determinó las políticas nacionales de investigación de salud y los programas prioritarios mediante una búsqueda de bases de datos ministeriales y gubernamentales relacionadas con instituciones de atención de salud. Se llevó a cabo una búsqueda ajustada al período de enero del 2002 a febrero del 2012 en PubMed, LILACS, Health Research Web y otras fuentes. El estudio excluyó las investigaciones organizadas por instituciones gubernamentales y estrategias nacionales específicas sobre áreas de enfermedades particulares. Se compararon los métodos de establecimiento de prioridades con los "nueve temas comunes para unas prácticas adecuadas en materia de prioridades de investigación de salud". Se compararon las prioridades nacionales de investigación de salud con las de los Objetivos de Desarrollo del Milenio (ODM) de la Organización Mundial de la Salud. RESULTADOS: De los 18 países latinoamericanos evaluados, 13 disponían de documentos que establecían las prioridades nacionales de investigación de salud; además, el Consejo del Caribe de Investigación de Salud disponía de un programa de investigaciones dirigido a sus 19 integrantes. Estos 14 informes variaban ampliamente en cuanto a objetivos, contenido, difusión y ejecución; la mayor parte de ellos proporcionaban una lista de áreas estratégicas, sugerencias o subprioridades para cada país, sin embargo, eran pocos los que proponían temas y cuestiones específicos de investigación. CONCLUSIONES: Se podrían mejorar los informes futuros mediante una descripción más detallada del método integral empleado para determinar las prioridades, del proceso de recopilación de información y de las prácticas que deben emprenderse una vez fijadas las prioridades. Es necesario mejorar la calidad de los métodos utilizados y coordinar las iniciativas regionales a medida que los países tratan de cumplir los ODM.

Mapping of available health research and development data: what's there, what's missing, and what role is there for a global observatory?

The need to align investments in health research and development (R&D) with public health demands is one of the most pressing global public health challenges. We aim to provide a comprehensive description of available data sources, propose a set of indicators for monitoring the global landscape of health R&D, and present a sample of country indicators on research inputs (investments), processes (clinical trials), and outputs (publications), based on data from international databases. Total global investments in health R&D (both public and private sector) in 2009 reached US$240 billion. Of the US$214 billion invested in high-income countries, 60% of health R&D investments came from the business sector, 30% from the public sector, and about 10% from other sources (including private non-profit organisations). Only about 1% of all health R&D investments were allocated to neglected diseases in 2010. Diseases of relevance to high-income countries were investigated in clinical trials seven-to-eight-times more often than were diseases whose burden lies mainly in low-income and middle-income countries. This report confirms that substantial gaps in the global landscape of health R&D remain, especially for and in low-income and middle-income countries. Too few investments are targeted towards the health needs of these countries. Better data are needed to improve priority setting and coordination for health R&D, ultimately to ensure that resources are allocated to diseases and regions where they are needed the most. The establishment of a global observatory on health R&D, which is being discussed at WHO, could address the absence of a comprehensive and sustainable mechanism for regular global monitoring of health R&D.