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Publication Years
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Robust clinical research capacity in low- and middle-income countries is key to stemming the spread of epidemics, according to a new report from the International Vaccines Task Force (IVTF). The rep
...
ort lays out how to develop the political support, financing and coordination required to build this capacity as a crucial component of global epidemic preparedness. The IVTF was convened by the World Bank Group (WBG) and the Coalition for Epidemic Preparedness Innovations (CEPI) in October 2017.
more
Integrating Clinical Research into Epidemic Response: The Ebola Experience
Gerald Keusch, Keith McAdam, Patricia Cuff, Michelle Mancher, and Emily R. Busta
National Academies of Sciences, Engineering, and Medicine
(2017)
C1
The 2014–2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Repub
...
lic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014–2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak.
more
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property fo
...
r unlimited proliferation, differentiation to cells of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
more
Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical
...
research and/or patient care so as to provide quality data which can be used for health research and patient treatment. As the use of laboratory tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
more
Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr
...
am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
more
The roadmap describes the actions needed to
achieve the three development goals for TB
vaccines set by the WHO:
1. A safe, effective and affordable TB vaccine
for adolescents and adults.
2. An affordable TB vaccine for neonates and
infants with improved safety and efficacy.
3. A therapeutic v
...
accine to improve TB
treatment outcomes
more
treat TB
Description of Research Outputs, 2009 - 2014
To support its R&D activities on Chagas disease, DNDi launched the Chagas Clinical Research Platform (CCRP). The platform brings together partners, experts, and stakeholders to provide support for e
...
valuation and development of new treatments for Chagas disease. The patient-centred platform aims to facilitate clinical research, provide a forum for technical discussions, develop a critical mass of expertise, and strengthen institutional research capacities. In addition, it identifies and reviews priority needs, works towards standardization of methodology to assess drug efficacy and reviews alternatives for using current approved drugs (new schemes, doses, combination) and special scenarios (resistance).
more
The Committee discussed the implications for preparedness for smallpox-like events reflected by the ongoing COVID-19 pandemic. The Committee noted how quickly diagnostics and vaccines could be developed and deployed when resources and political will were abundant. This rapidity was also due to the f
...
act that the genetic sequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had been shared worldwide. It was noted that in one country SARS-CoV-2 had been reconstructed in a laboratory from the viral genome sequence before the first case of COVID-19 had been reported, highlighting the benefits of synthetic biology technologies for accelerated development of diagnostics as well as the oft-described potential risks. Lessons learned about clinical care during the COVID-19 pandemic were also discussed.
more
The document "Diabetes and Ramadan: Practical Guidelines 2021," published by Elsevier, provides updated guidance for managing diabetes during Ramadan fasting. Developed by the International Diabetes Federation (IDF) and the Diabetes and Ramadan (DAR) International Alliance, the guidelines address ke
...
y aspects for individuals with diabetes who choose to fast, including risk assessment, blood glucose monitoring, insulin and medication adjustments, and the management of special populations (such as pregnant women, the elderly, and those with chronic conditions). Emphasis is placed on individualized patient education before Ramadan to ensure safe fasting practices and minimize risks like hypoglycemia and hyperglycemia.
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Toolkit for research and development of paediatric antiretroviral drugs and formulations
World Health Organization (WHO); Unitaid; Unicef; et al.
World Health Organization (WHO); Unitaid; Unicef; et al.
(2018)
C_WHO
WHO and UNITAID
in collaboration with IMPAACT (International Maternal Pediatric Adolescent AIDS Clinical Trials) network, PENTA (Paediatric European Network for Treatment of AIDS) foundation and experts from the Paediatric Antiretroviral Working Gr
...
oup
more
This report presents an analysis of antibacterial agents in preclinical (third annual review) and clinical (fifth annual review) development. The analysis covers traditional (direct-acting small molecules) and non-traditional antibacterial agents in
...
development worldwide. It evaluates to what extent the present pipeline addresses infections caused by WHO Priority Pathogens, Mycobacterium tuberculosis and Clostridioides difficile. The report also provides an assessment of the traditional agents with respect to whether they meet a set of predefined criteria for innovation, namely absence of known cross-resistance, new target, mode of action and/or class. It also includes an overview of the agents that obtained authorization since 1 July 2017.
more
PLoS ONE 7(12): e52986. doi:10.1371/journal.pone.0052986. Opern Access please download from the website
PLoS Negl Trop Dis 15(8): e0009697. Chagas disease (CD), caused by the parasite Trypanosoma cruzi, affects ~6–7 million people worldwide. Significant limitations still exist in our understanding of CD. Harnessing individual participant data (IPD) from studies could support more in-depth analyses t
...
o address the many outstanding research questions. This systematic review aims to describe the characteristics and treatment practices of clinical studies in CD and assess the breadth and availability of research data for the potential establishment of a data-sharing platform.
more
The report presents current information (updated to September 2015) on candidate vaccines, therapies and medical devices for Ebola and gives an overview of completed and on-going trials.
Nothing About Us Without RIGHTS—Meaningful Engagement of Children and Youth: From Research Prioritization to Clinical Trials, Implementation Science, and Policy
C. Oliveras; L. Cluver; S. Bernays; A. Armstrong
JAIDS Journal of Acquired Immune Deficiency Syndromes; PubMed
(2018)
C2
Supplement Article
J Acquir Immune Defic Syndr Volume 78, Supplement 1, August 15, 2018 www.jaids.com
As of 12 December 2022, over 645 million people worldwide have been diagnosed with COVID-19, with over 6.6 million deaths (4).
The Omicron variant, which emerged in late November 2021, and its subvariants, are now the dominant circulating viruses, contributing to the ongoing surge in several countr
...
ies (4). Vaccination has substantially reduced case numbers and hospitalizations in many countries,but limitations in global access to vaccines mean that many populations, including those in low- and middle-income countries, remain vulnerable. Even in vaccinated individuals, uncertainties remain about duration of protection and efficacy, and the degree of crossprotection with new variants.
There remains a need for more effective treatment and management for those affected by COVID-19. The pandemic – and the
explosion of both research and misinformation – has highlighted the need for trustworthy, accessible and regularly updated living
guidelines to place emerging findings into context and provide clear recommendations for clinical practice
more
