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,
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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.
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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
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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.
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Document No. : FDA/SMC/CTD/GL-CCT/2013/01
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
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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.
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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
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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.
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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 prov
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ide 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.
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The WHO COVID-19 Clinical management: living guidance contains the Organization’s most up-to-date recommendations for the clinical management of people with COVID-19. Providing guidance that is co
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mprehensive and holistic for the optimal care of COVID-19 patients throughout their entire illness is important. The latest version of this living guideline is available in pdf format (via the ‘Download’ button) and via an online platform, and is updated regularly as new evidence emerges. No further updates to the previous existing recommendations were made in this latest version.
This updated (fifth) version contains 16 new recommendations for the rehabilitation of adults with post COVID-19 condition (see Chapter 24)
This updated (fourth) version contains three new recommendations regarding hospitalized patients with severe or critical COVID-19
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PLoS ONE 7(12): e52986. doi:10.1371/journal.pone.0052986. Opern Access please download from the website
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M
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edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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