Data sharing and reuse in clinical research: Are we there yet? A cross-sectional study on progress, challenges and opportunities in LMICs.

Data sharing holds promise to accelerate innovative discoveries through artificial intelligence (AI) and traditional analytics. However, it remains unclear whether these prospects translate into tangible benefits in improving health care and scientific progress. In this cross-sectional study, we investigate current data reuse practices and explore ways to enhance the use of existing data in clinical research, focusing on low- and middle-income countries.

Professional development scheme: a tool to measure health research competencies in healthcare professionals.

Significant investments have been made in health research capacity development (HRCD) initiatives focusing on individual professionals and institutional frameworks. However, prevailing approaches often prioritise specific research projects over explicit strategies for strengthening the capacities of health research professionals (HRPs) particularly in low and middle-income countries. Despite recognition of its limitations, this implicit approach persists resulting in a lack of effective HRCD strategies.

Ongoing mpox outbreak in Kamituga, South Kivu province, associated with monkeypox virus of a novel Clade I sub-lineage, Democratic Republic of the Congo, 2024.

Since the beginning of 2023, the number of people with suspected monkeypox virus (MPXV) infection have sharply increased in the Democratic Republic of the Congo (DRC). We report near-to-complete MPXV genome sequences derived from six cases from the South Kivu province. Phylogenetic analyses reveal that the MPXV affecting the cases belongs to a novel Clade I sub-lineage.

Investigating the Secondary Use of Clinical Research Data: Protocol for a Mixed Methods Study.

Background: The increasing emphasis to share patient data from clinical research has resulted in substantial investments in data repositories and infrastructure. However, it is unclear how shared data are used and whether anticipated benefits are being realized.

Objective: The purpose of our study is to examine the current utilization of shared clinical research data sets and assess the effects on both scientific research and public health outcomes.

Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic: a qualitative study.

Background: Good governance and regulatory supervision are required to conduct research in an international public health emergency context and to ensure compliance with ethical standards. The "Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic" study is a regional effort in which research ethics stakeholders participated in addressing research ethics governance and preparedness response challenges to the COVID-19 pandemic in Central America and the Dominican Republic.

Methods: A qualitative action research study was conducted following a participatory approach.

Enabling evidence to tackle everyday diseases to mitigate another pandemic.

The next emergent novel pathogen is likely to occur where the ability to undertake health research and collect life-saving data is lacking. Without embedded and ongoing research activities in place spotting and stopping a new threat is not possible, thereby enabling undetected infection and unchecked transmission within a community. Without local existing capabilities to collect such data delay is catastrophic.

The European & Developing Countries Clinical Trials Partnership (EDCTP) Knowledge Hub: developing an open platform for facilitating high-quality clinical research.

There is stark global inequity in health research in terms of where studies happen, who leads the research and the ultimate beneficiaries of the results generated. Despite significant efforts made, limited research ideas are conceptualised and implemented in low-resource settings to tackle diseases of poverty, and this is especially true in sub-Saharan Africa. There is strong evidence to show that the barriers to locally led research do not vary largely between disease, study type and location and can be largely solved by addressing these common gaps.

The legacy of ZikaPLAN: a transnational research consortium addressing Zika.

Global health research partnerships with institutions from high-income countries and low- and middle-income countries are one of the European Commission's flagship programmes. Here, we report on the ZikaPLAN research consortium funded by the European Commission with the primary goal of addressing the urgent knowledge gaps related to the Zika epidemic and the secondary goal of building up research capacity and establishing a Latin American-European research network for emerging vector-borne diseases. Five years of collaborative research effort have led to a better understanding of the full clinical spectrum of congenital Zika syndrome in children and the neurological complications of Zika virus infections in adults and helped explore the origins and trajectory of Zika virus transmission.

Creating equity in health research to drive more and better evidence.

Health research is rapidly changing with evidence being gathered through new agile methods. This evolution is critical but must be globally equitable so the poorest nations do not lose out. We must harness this change to better tackle the daily burden of diseases that affect the most impoverished populations and bring research capabilities to every corner of the world so that rapid and fair responses to new pathogen are possible; anywhere they appear.

Engaging local health research communities to enhance long-term capacity building in Brazil.

The '2019 Research Capacity Network (REDe) workshop series' was an initiative led by Brazil-based REDe coordinators and The Global Health Network (TGHN) in partnership with Brazilian researchers interested in arboviruses. This workshop initiative has provided crucial training to the local research community offering transferable skills to effectively respond to health emergencies, with an impact beyond arboviral diseases, as evidenced by further activities undertaken during the COVID-19 pandemic. The success of this approach resulted from several factors, especially the workshops' local leadership and the combination of in-person training with online sharing of the resources generated in the local language.

Setting up a pragmatic clinical trial in a low-resource setting: A qualitative assessment of GoLBeT, a trial of podoconiosis management in Northern Ethiopia.

Background: Clinical trials are often perceived as being expensive, difficult and beyond the capacity of healthcare workers in low-resource settings. However, in order to improve healthcare coverage, the World Health Organization (WHO) World Health Report 2013 stated that all countries need to become generators as well as recipients of data. This study is a methodological examination of the steps and processes involved in setting up the Gojjam Lymphoedema Best Practice Trial (GoLBeT; ISRCTN67805210), a highly pragmatic clinical trial conducted in northern Ethiopia.

Measuring research capacity development in healthcare workers: a systematic review.

Objectives: A key barrier in supporting health research capacity development (HRCD) is the lack of empirical measurement of competencies to assess skills and identify gaps in research activities. An effective tool to measure HRCD in healthcare workers would help inform teams to undertake more locally led research. The objective of this systematic review is to identify tools measuring healthcare workers' individual capacities to conduct research.

Excess mortality among people with podoconiosis: secondary analysis of two Ethiopian cohorts.

Background: While morbidity attributable to podoconiosis is relatively well studied, its pattern of mortality has not been established.

Methods: We compared the age-standardised mortality ratios (SMRs) of two datasets from northern Ethiopia: podoconiosis patients enrolled in a 1-y trial and a Health and Demographic Surveillance System cohort.

Results: The annual crude mortality rate per 1000 population for podoconiosis patients was 28.

The remaining unknowns: a mixed methods study of the current and global health research priorities for COVID-19.

Introduction: In March 2020, the WHO released a Global Research Roadmap in an effort to coordinate and accelerate the global research response to combat COVID-19 based on deliberations of 400 experts across the world. Three months on, the disease and our understanding have both evolved significantly. As we now tackle a pandemic in very different contexts and with increased knowledge, we sought to build on the work of the WHO to gain a more current and global perspective on these initial priorities.

Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study.

Background: Cutaneous leishmaniasis (CL) is a disease that often affects exposed skin areas and may heal leaving lifelong scars. Patients' expectations from treatment are rarely considered in drug development for CL. An initiative aiming to address shortcomings in clinical trial design and conduct for CL treatments involving the researchers' community is on-going.

Cost-effectiveness and social outcomes of a community-based treatment for podoconiosis lymphoedema in the East Gojjam zone, Ethiopia.

Background: Podoconiosis is a disease of the lymphatic vessels of the lower extremities that is caused by chronic exposure to irritant soils. It results in leg swelling, commonly complicated by acute dermatolymphangioadenitis (ADLA), characterised by severe pain, fever and disability.

Methods: We conducted cost-effectiveness and social outcome analyses of a pragmatic, randomised controlled trial of a hygiene and foot-care intervention for people with podoconiosis in the East Gojjam zone of northern Ethiopia.

ZikaPLAN: addressing the knowledge gaps and working towards a research preparedness network in the Americas.

Zika Preparedness Latin American Network (ZikaPLAN) is a research consortium funded by the European Commission to address the research gaps in combating Zika and to establish a sustainable network with research capacity building in the Americas. Here we present a report on ZikaPLAN`s mid-term achievements since its initiation in October 2016 to June 2019, illustrating the research objectives of the 15 work packages ranging from virology, diagnostics, entomology and vector control, modelling to clinical cohort studies in pregnant women and neonates, as well as studies on the neurological complications of Zika infections in adolescents and adults. For example, the Neuroviruses Emerging in the Americas Study (NEAS) has set up more than 10 clinical sites in Colombia.

An international qualitative study exploring patients' experiences of cutaneous leishmaniasis: study set-up and protocol.

Introduction: Lack of investments in drug development, lack of standardisation of clinical trials and the complexity of disease presentations contribute to the current lack of effective, safe and adapted treatments for cutaneous leishmaniasis (CL). One aspect concerns outcomes affecting patients' quality of life (QoL): these are hardly assessed in trials, despite potential functional and/or aesthetic impairment caused by CL, which typically affects disadvantaged and vulnerable people living in rural areas. Here, we describe the approach used to bring perspectives of patients with CL into designing and assessing treatments.

Lymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis in northern Ethiopia (GoLBeT): a pragmatic randomised controlled trial.

Background: Podoconiosis (also known as endemic, non-filarial elephantiasis) affects about 4 million subsistence farmers in tropical Africa. Poor awareness of the condition and inadequate evidence for the efficacy of treatment mean that no government in an endemic country yet offers lymphoedema management for patients with podoconiosis. Among patients with filarial lymphoedema, trials suggest that limb care is effective in reducing the most disabling sequelae: episodes of acute dermatolymphangioadenitis.

Global health trials methodological research agenda: results from a priority setting exercise.

Background: Methodological research into the design, conduct, analysis and reporting of trials is essential to optimise the process. UK specialists in the field have established a set of top priorities in aid of this research. These priorities, however, may not be reflected in the needs of similar research in low- to middle-income countries (LMICs) with different healthcare provision, resources and research infrastructure.