Participant Manual September 2009
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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This new edition and fully updated publication replaces the 2012 UCG and is being circulated free of charge to all public and private sector prescribers, pharmacists, and regulatory authorities in the country
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
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 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 for unlimited proliferation, differentiation to cells
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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.
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This new guideline on non-clinical interventions to reduce unnecessary caesarean sections incorporates the views, fears and beliefs of both women and health professionals about caesarean sections. It also considers the complex dynamics and limitatio
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ns of health systems and organizations and relationships between women, health professionals and organization of health care services.
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Background: The World Health Organization (WHO) published a clinical case definition of post COVID-19
condition, by a Delphi consensus, on 6 October 2021. That process concluded that a separate definition
may be applicable for children. It is impo
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rtant to understand the frequency, characteristics and risk factors
that lead to post COVID-19 condition, along with its impact on everyday functioning and development of
children and adolescents. Long-term outcomes of the condition are currently unknown and need to be
studied. For these reasons, a globally standardized clinical case definition is needed.
Aim: To develop a globally relevant standardized clinical case definition for children and adolescents by
building on the WHO clinical case definition for post COVID-19 condition in adults.
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The purpose of this Guideline is to provide evidence-based recommendations that promote and sustain the undergraduate nursing student’s application of knowledge to practice in a variety of clinical learning environments. The Guideline explores the
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relationships among and between students and nursing educators, nursing staff, preceptors, and diverse health-care team members, and it considers their influence on the quality of practice education, professional socialization, and nursing excellence.
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WHO has published the first-ever guidance on the clinical management of diphtheria. The only previously available guidance was an operational protocol. The new guidance followed the rigorous process for developing guidance at WHO.
It addresses th
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e use of Diphtheria Antitoxin (DAT) in the treatment of diphtheria. There is a worldwide shortage of DAT and evidence based recommendations on the use of DAT were requested by many Member States.
The guidance also includes new recommendations on antibiotics. In patients with suspected or confirmed diphtheria, WHO recommends using macrolide antibiotics (azithromycin, erythromycin) rather than penicillin antibiotics.
This clinical practice guideline has been rapidly developed recognizing the global increase in diphtheria outbreaks. Outbreaks of diphtheria in Nigeria, Guinea and neighbouring countries in 2023 have highlighted the urgent need for evidence-based clinical practice guidelines for the treatment of diphtheria. Given the sporadic nature of outbreaks, many clinicians in the affected regions have never managed acute diphtheria and its related complications. Diphtheria remains a neglected disease and vaccination is the top priority. At the same time, for patients with diphtheria, access to antibiotics, DAT and supportive care can be lifesaving.
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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
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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.
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The purpose of this pocketbook is to provide clear guidance on current best management practices for VHF across health-care facilities