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2
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
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 report 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
Document No. : FDA/SMC/CTD/GL-CCT/2013/01
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 ex
...
perts from the Paediatric Antiretroviral Working Group
more
August 2020, The Africa Joint Continental Strategy for COVID-19 is underpinned by the need to limit transmission, prevent deaths and reduce associated harms. Participation by African nations in clinical tr
...
ials is an essential step to ensure that sufficient data is generated on the safety and efficacy of the most promising vaccine candidates among the region’s populations.
While current COVID-19 clinical trial activity on the continent is limited, Africa has substantial experience and capabilities to conduct clinical trials for preventative vaccines across a range of diseases, and many organizations on the continent are working tirelessly to help prepare additional trials on potential COVID-19 vaccines. As the number of candidate vaccines in the development pipeline continues to increase, it will be important for organizations responsible for managing clinical trials in the region to partner with vaccine developers to identify potential and appropriate trial locations, provide support to remove any critical obstacles impeding commencement and progress of trials, and to provide oversight ensuring that trials are conducted safely and ethically.
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
This version of Field Trials of Health Interventions includes seven new chapters on conducting systematic literature reviews, trial
governance, preliminary studies and pilot testing, budgeting and accounting, intervention costing and economic analy
...
sis, and Phase IV studies. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in ‘field trials’. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. This manual was designed to provide guidance on the practical issues in great detail
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
The waves of yellow fever transmission in the Region of the Americas in 2016–2018 involved the largest number of human and epizootic cases to be reported in several decades. Yellow fever is a serious viral hemorrhagic disease that poses a challenge for health professionals. It requires early recog
...
nition of signs and symptoms, which are often nonspecific, and it can mimic other acute febrile syndromes. Early detection of suspected or confirmed cases, monitoring of vital signs, life support measures, and treatment of acute kidney failure continue to be the recommended strategies for case management. This report is the result of discussions among experienced specialists in the Americas on the clinical management of yellow fever patients, especially during outbreaks and epidemics, in the context of current medical and scientific evidence and taking into account the technical guidelines already available in the countries of the Region. It includes flowcharts for initially addressing patients with clinical suspicion of yellow fever and proposes a minimum package of laboratory tests that may be useful in contexts where resources are limited. In addition, it considers aspects of health system organization for dealing with yellow fever outbreaks and epidemics.
more
HIV/AIDS Programme
Evidence-based guidelines are one of the most useful tools for improving public health and clinical practice. Their purpose is to formulate interventions based on strong evidence of efficacy, avoid unnecessary risks, use resources efficiently, reduc
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e clinical variability and, in essence, improve health and ensure quality care, which is the purpose of health systems and services. These guidelines were developed following the GRADE methodology, with the support of a panel of clinical experts from different countries, all convened by the Pan American Health Organization. By responding to twelve key questions about the clinical diagnosis and treatment of dengue, chikungunya, and Zika, evidence-based recommendations were formulated for pediatric, youth, adult, older adult, and pregnant patients who are exposed to these diseases or have a suspected or confirmed diagnosis of infection. The purpose of the guidelines is to prevent progression to severe forms of these diseases and the fatal events they may cause. The recommendations are intended for health professionals, including general, resident, and specialist physicians, nursing professionals, and medical and nursing students, who participate in caring for patients with suspected dengue, chikungunya, or Zika. They are also intended for health unit managers and the executive teams of national arboviral disease prevention and control programs, who are responsible for facilitating the process of implementing these guidelines.
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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.
UNAIDS and the World Health Organization have published this updated guidance on ethical considerations in HIV prevention trials. The new guidance is the result of a year-long process that saw more than 80 experts and members of the public give inpu
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ts and is published 21 years after the first edition appeared.
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