Laboratory challenges conducting international clinical research in resource-limited settings.
Ontology highlight
ABSTRACT:
SUBMITTER: Fitzgibbon JE
PROVIDER: S-EPMC3893068 | biostudies-literature | 2014 Jan
REPOSITORIES: biostudies-literature
Publications
Laboratory challenges conducting international clinical research in resource-limited settings.
Fitzgibbon Joseph E JE Wallis Carole L CL
Journal of acquired immune deficiency syndromes (1999) 20140101
There are many challenges to performing clinical research in resource-limited settings. Here, we discuss several of the most common laboratory issues that must be addressed. These include issues relating to organization and personnel, laboratory facilities and equipment, standard operating procedures, external quality assurance, shipping, laboratory capacity, and data management. Although much progress has been made, innovative ways of addressing some of these issues are still very much needed. ...[more]
Similar Datasets
Project description:BackgroundMultinational clinical trials are logistically complex and require close coordination between various stakeholders. They must comply with global clinical standards and are accountable to multiple regulatory and ethical bodies. In resource-limited settings, it is challenging to understand how to apply global clinical standards to international, national, and local factors in clinical trials, making multiple-level stakeholder engagement an important element in the successful conduct of these clinical trials.Main bodyDuring the planning and implementation of a large multinational clinical trial for intermittent preventive treatment of malaria in pregnancy in resource-limited areas of sub-Saharan Africa, we encountered numerous challenges, which required implementation of a range of engagement measures to ensure compliance with global clinical and regulatory standards. These challenges included coordination with ongoing global malaria efforts, heterogeneity in national regulatory structures, sub-optimal healthcare infrastructure, local practices and beliefs, and perspectives that view healthcare providers with undue trust or suspicion. In addition to engagement with international bodies, such as the World Health Organization, the Malaria in Pregnancy Consortium, the Steve Biko Centre for Bioethics, and the London School of Hygiene and Tropical Medicine, in order to address the challenges just described, Pfizer Inc. and Medicines for Malaria Venture (the "Sponsoring Entities" for these studies) and investigators liaised with national- and district-level stakeholders such as health ministers and regional/local community health workers. Community engagement measures undertaken by investigators included local meetings with community leaders to explain the research aims and answer questions and concerns voiced by the community. The investigators also engaged with family members of prospective trial participants in order to be sensitive to local practices and beliefs.ConclusionEngagement with key stakeholders at international and national levels enabled the Sponsoring Entities to address challenges by aligning the study design with the requirements of health and regulatory agencies and to understand and address healthcare infrastructure needs prior to trial initiation. Local stakeholder engagement, including community members, study participants, and family enabled the investigators to address challenges by ensuring that study design and conduct were adapted to local considerations and ensuring accurate information about the study aims was shared with the public.Trial registrationClinicalTrials.gov, ID: NCT01103063 . Registered on 7 April 2010.
| S-EPMC5863846 | biostudies-literature
Project description: Not available
| S-EPMC7270833 | biostudies-literature
Project description:Smaller, more affordable, and more portable MRI brain scanners offer exciting opportunities to address unmet research needs and long-standing health inequities in remote and resource-limited international settings. Field-based neuroimaging research in low- and middle-income countries (LMICs) can improve local capacity to conduct both structural and functional neuroscience studies, expand knowledge of brain injury and neuropsychiatric and neurodevelopmental disorders, and ultimately improve the timeliness and quality of clinical diagnosis and treatment around the globe. Facilitating MRI research in remote settings can also diversify reference databases in neuroscience, improve understanding of brain development and degeneration across the lifespan in diverse populations, and help to create reliable measurements of infant and child development. These deeper understandings can lead to new strategies for collaborating with communities to mitigate and hopefully overcome challenges that negatively impact brain development and quality of life. Despite the potential importance of research using highly portable MRI in remote and resource-limited settings, there is little analysis of the attendant ethical, legal, and social issues (ELSI). To begin addressing this gap, this paper presents findings from the first phase of an envisioned multi-staged and iterative approach for creating ethical and legal guidance in a complex global landscape. Section 1 provides a brief introduction to the emerging technology for field-based MRI research. Section 2 presents our methodology for generating plausible use cases for MRI research in remote and resource-limited settings and identifying associated ELSI issues. Section 3 analyzes core ELSI issues in designing and conducting field-based MRI research in remote, resource-limited settings and offers recommendations. We argue that a guiding principle for field-based MRI research in these contexts should be including local communities and research participants throughout the research process in order to create sustained local value. Section 4 presents a recommended path for the next phase of work that could further adapt these use cases, address ethical and legal issues, and co-develop guidance in partnership with local communities.
| S-EPMC8382487 | biostudies-literature
Project description:BackgroundMycetoma is a chronic mutilating disease of the skin and the underlying tissues caused by fungi or bacteria. Although recently included in the list of neglected tropical diseases by the World Health Organization, strategic control and preventive measures are yet to be outlined. Thus, it continues to pose huge public health threat in many tropical and sub-tropical countries. If not detected and managed early, it results into gruesome deformity of the limbs. Its low report and lack of familiarity may predispose patients to misdiagnosis and delayed treatment initiation. More so in situation where diagnostic tools are limited or unavailable, little or no option is left but to clinically diagnose these patients. Therefore, an overview of clinical course of mycetoma, a suggested diagnostic algorithm and proposed use of materials that cover the exposed susceptible parts of the body during labour may assist in the prevention and improvement of its management. Furthermore, early reporting which should be encouraged through formal and informal education and sensitization is strongly suggested.Main textAn overview of the clinical presentation of mycetoma in the early and late phases, clues to distinguish eumycetoma from actinomycetoma in the field and the laboratory, differential diagnosis and a suggested diagnostic algorithm that may be useful in making diagnosis amidst the differential diagnosis of mycetoma is given. Additionally, a proposed preventive measures which may be helpful in the community is also provided. Since treatment is currently based on expert opinion, we encourage active research to establish treatment guideline for it.ConclusionSince delay in visiting health facility results into gruesome complication, early presentation, recognition and initiation of appropriate choice of regimen is helpful in reducing complications. The clinical overview of mycetoma and the suggested algorithm may enhance suspicion and possibly increase recognition of mycetoma in the community and further guide in differentiation of eumycetoma from actinomycetoma. There is an urgent need for research funding for mycetoma, a disease plagued by severe physical disabilities and social stigma leading to isolation.
| S-EPMC6085652 | biostudies-literature
Project description:IntroductionGlomerular diseases are the leading drivers of nondiabetic chronic kidney disease disability-adjusted life years in resource-limited countries. Proper diagnosis and treatment relies on resources including kidney biopsy, ancillary testing, and access to evidence-based therapies.MethodsWe conducted a cross-sectional internet-based survey cascaded through society mailing lists among nephrologists in countries of Asia, Africa, and Eastern Europe. We collected the data on respondent demographics, their ability to perform and appropriately interpret a kidney biopsy, and their access to complementary investigations and treatment practices.ResultsA total of 298 kidney care specialists from 33 countries (53.3% from Asia and 44.6% from Africa; 64% from academic or university hospitals) participated in the survey. Of these specialists, 85% performed kidney biopsy. About 61% of the respondents could not obtain a kidney biopsy in more than 50% of patients with suspected glomerular disease. About 43% of the respondents from Africa had access to only light microscopy. Overall, the inability to undertake and fully evaluate a biopsy and perform ancillary investigations were more profound in Africa than in Asia. Overall, 59% of participants reported that more than 75% of their patients meet the cost of diagnosis and treatment by out-of-pocket payments. Empirical use of immunosuppression was higher in Africa than in Asia. The main barriers for diagnosis and treatment included delayed presentation, incomplete diagnostic work-up, and high cost of treatment.ConclusionMajor system-level barriers impede the implementation of guideline-driven approaches for diagnosis and treatment of patients with glomerular disease in resource-limited countries.
| S-EPMC9546742 | biostudies-literature
Project description:Background: Approximately 40 million people in need of palliative care worldwide, while 80% of them live in low- and middle-income countries. Kazakhstan, a low-to middle-income country with a reforming healthcare system, is committed to improving quality and accessibility of care for its 100,000 terminal patients in need of palliative care. Policy Options and Recommendations: To join the group of countries where palliative care is available, accessible, and affordable, Kazakhstan must integrate palliative services into the mainstream healthcare system at all levels, from primary healthcare to hospices, and from major cities to remote villages. Based on the evidence thoroughly collected directly from the Ministry of Health, authors propose a feasible set of recommendations regarding palliative policy, pain relief, infrastructure, workforce, and education, which could be implemented in LMICs beyond Kazakhstan. Conclusion: This study presents an analysis of challenges, recent developments, and needs of palliative care in Kazakhstan, including funding, policy, workforce, education, and infrastructure, providing an evidence base and recommendations for future development of palliative care in Kazakhstan and in other LMICs.
| S-EPMC10476099 | biostudies-literature
Project description:Sepsis and septic shock are major contributors to the global burden of disease, with a large proportion of patients and deaths with sepsis estimated to occur in low- and middle-income countries (LMICs). There are numerous barriers to reducing the large global burden of sepsis including challenges in quantifying attributable morbidity and mortality, poverty, inadequate awareness, health inequity, under-resourced public health, and low-resilient acute health care delivery systems. Context-specific approaches to this significant problem are necessary on account of important differences in populations at-risk, the nature of infecting pathogens, and the healthcare capacity to manage sepsis in LMIC. We review these challenges and propose an outline of some solutions to tackle them which include strengthening the healthcare systems, accurate and early identification of sepsis the need for inclusive research and context-specific treatment guidelines, and advocacy. Specifically, strengthening pediatric intensive care units (PICU) services can effectively treat the life-threatening complications of common diseases, such as diarrhoea, respiratory infections, severe malaria, and dengue, thereby improving the quality of pediatric care overall without the need for expensive interventions. A thoughtful approach to developing paediatric intensive care services in LMICs begins with basic fundamentals: training healthcare providers in knowledge and skills, selecting effective equipment that is resource-appropriate, and having an enabling leadership to provide location-appropriate care. These basics, if built in sustainable manner, have the potential to permit an efficient pediatric critical care service to be established that can significantly improve sepsis and other critical care outcomes.
| S-EPMC8578780 | biostudies-literature
Project description:ObjectiveThe objective of this narrative review is to outline the current epidemiology and interventional research within the context of sepsis recovery, and to provide a summary of key priorities for future work in this area.BackgroundMorbidity and mortality secondary to sepsis disproportionately affects children, especially those in low- and middle-income countries (LMICs), where over 85% of global cases and deaths occur. These regions are plagued by poorly resilient health systems, widespread socio-economic deprivation and unique vulnerabilities such as malnutrition. Reducing the overall burden of sepsis will require a multi-pronged strategy that addresses all three important periods along the sepsis care continuum - pre-facility, facility and post-facility. Of these aspects, post-facility issues have been largely neglected in research, practice and policy, and are thus the focus of this review.MethodsRelevant data for this review was identified through a literature search using PubMed, through a review of the citations of select systematic reviews and from the personal repositories of articles collected by the authors. Data is presented within three sections. The first two sections on the short and long-term outcomes among sepsis survivors each outline the epidemiology as well as review relevant interventional research done. Where clear gaps exist, these are stated. The third section focuses on priorities for future research. This section highlights the importance of data (and data systems) and of innovative interventional approaches, as key areas to improve research of post-sepsis outcomes in children.ConclusionsDuring the initial post-facility period, mortality is high with as many children dying during this period as during the acute period of hospitalization, mostly due to recurrent illness (including infections) which are associated with malnutrition and severe acute disease. Long-term outcomes, often labelled as post-sepsis syndrome (PSS), are characterized by a lag in developmental milestones and suboptimal quality of life (QoL). While long-term outcomes have not been well characterized in resource limited settings, they are well described in high-income countries (HICs), and likely are important contributors to long-term morbidity in resource limited settings. The paucity of interventional research to improve post-discharge outcomes (short- or long-term) is a clear gap in addressing its burden. A focus on the development of improved data systems for collecting routine data, standardized definitions and terminology and a health-systems approach in research need to be prioritized during any efforts to improve outcomes during the post-sepsis phase.
| S-EPMC8578768 | biostudies-literature
Project description:A Good Clinical Practices (GCPs) course, based on the combination of theoretical modules with a practical training in real-life conditions, was held in 2010 in Burkina Faso. It was attended by 15 trainees from nine African, Asian, and Latin American countries. There were some discrepancies between the average good results at the end of the theoretical phase and the GCP application during the first days of the practical phase, underlying the difficulties of translating theoretical knowledge into good practices. Most of the findings were not unexpected and reflected the challenges commonly faced by clinical investigators in resource-poor contexts (i.e., the high workload at peripheral health facilities, the need to conciliate routine clinical activities with clinical research, and the risk of creating a double standard among patients attending the same health facility [free care for recruited patients versus user fees for non-recruited patients with the same medical condition]). Even if limited in number and time, these observations suggest that a theoretical training alone may not be sufficient to prepare trainees for the challenges of medical research in real-life settings. Conversely, when a practical phase immediately follows a theoretical one, trainees can immediately experience what the research methodology implicates in terms of work organization and relationship with recruited and non-recruited patients. This initial experience shows the complexity of translating GCP into practice and suggests the need to rethink the current conception of GCP training.
| S-EPMC3617841 | biostudies-literature
Project description:Despite increasing availability of anti-retroviral therapy, invasive cryptococcal disease continues to be a leading cause of death among HIV-infected individuals in resource-limited settings. Screening asymptomatic HIV-infected individuals with advanced immunosuppression for serum cryptococcal antigen clearly identifies a population at high risk of cryptococcal meningitis and death. However, screening with serum cryptococcal antigen alone identifies a heterogeneous clinical population, many of whom have mild clinical symptoms, sub-clinical meningeal infection, or fungemia. Currently, there is wide variation in practice and little evidence to guide the use of anti-fungal and anti-retroviral treatment for asymptomatic cryptococcal antigenemia (ACA). Furthermore, implementing a targeted screening and treatment intervention for ACA presents numerous operational challenges for already overburdened health care systems in resource-limited settings. While such an intervention shows promise, there are critical gaps in our understanding of ACA and its implications in the outpatient setting and an urgent need for additional research in this area.
| S-EPMC3809900 | biostudies-literature