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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 scope of this PPC document is to serve as a guide to address the unmet public health need for a PPE system that protects the HW-F in tropical climate
s while caring for patients and providing heavy duty essential health services.
The characteristics described in this guidance are targeted fo
...
r PPE used in
health clinics, hospitals and communities in low resource settings where there is lack of advanced environmental controls and equipment. The purpose is to ensure harmonization in PPE design and its use to avoid confusion and exacerbating the risk of infections in HW-F. The principles of this PPC document can also be considered in risk reduction strategies
in other healthcare settings.
more
WHO Prequalification of Diagnostics Programme - Public report (Product:BDFACSCountTM InstrumentSystemwithFACSCountTM ControlKitandBD FACSCountTM CD4ReagentKit(AbsoluteandPercentageCD4+Counts) )
World Health Organization
(2016)
C_WHO
Product:BDFACSCountTM InstrumentSystemwithFACSCountTM ControlKitandBD FACSCountTM CD4ReagentKit(AbsoluteandPercentageCD4+Counts)
Number: PQDx 0133-045-00
0133-045-00 WHO
PQDx PR
June/2016, version 2.0
Soil-transmitted helminths are a group of intestinal worms that include Ascaris lumbricoides (giant roundworm), Trichuris trichiura (whipworm), and Ancylostoma spp. (A. duodenale, A. ceylanicum) and Necator americanus (hookworms). Despite the clear biological differences among the different species,
...
their transmission is characterized by the same sequence of events: (i) infected individuals excrete worm eggs through their stool in soil; (ii) under optimal conditions of moisture and temperature the excreted eggs develop into infectious stages; and (iii) finally, infection occurs through oral uptake (Ascaris, Ancylostoma and Trichuris) or skin penetration (Ancylostoma and Necator) of these infectious stages (embryonated eggs and third stage larvae) that reside in the soil and/or in the environment (referring to their common name).
more
On 15–16 December 2020, WHO and the Medicines for Malaria Venture co-convened a technical consultation to consider the preferred product characteristics (PPCs) for drugs used in malaria chemoprevention. The main goal of the technical consultation
...
was to agree on the most important PPCs for drugs to protect populations from malaria (chemoprevention), while considering relevant measures of efficacy and the safety data needed to support WHO policy recommendations.
more
Procedures Manual - Medicines registration in Madagascar - 2016 version
5th revised edition.
This document provides a ranking of medically important antimicrobials for risk management of antimicrobial resistance due to non-human use. The current revision took place at the seventh meeting of the AGISAR held in Raleigh, United States of America in 2016.
Japan has been implementing projects of global extension of medical technologies under an official development assistance policy to improve public health and medicine by promoting Japanese medical technologies worldwide. The current work examines th
...
e impact and goals of implementing this new scheme. The scheme has involved dozens of projects that sent Japanese experts to partner countries and that invited their counterparts to Japan to showcase Japanese medical technologies. Approximately 50 projects have been implemented in 24 countries over 5 years, and 19,638 individuals have been trained. As a result, the introduced technology was adopted in national guidelines in 4 projects and the introduced equipment was procured in the partner country in 17 projects. In total, 912,334 individuals have benefitted from the introduction of these medical technologies. The concept of "creating shared value" (CSV) could help promote project success by both creating economic value and encouraging social progress. However, the sustainability of that business model remains in question in terms of the internationalization of CSV. Several successful projects improved medical care and led to new business opportunities.
more
WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: AiDtm anti-HIV 1+2 ELISA, Number: PQDx 0006-005-00)
World Health Organization
(2016)
C_WHO
PQDx 0006-005-00 WHO
PQDx PR
February/2016, version 2.0
Theodor Bilharz, a German professor of anatomy and chief of surgery at the Kasr El Ani Hospital of Cairo from 1850, first identified an infective organism, Distomum hematobium in 1851, which was renamed Schistosoma haematobium in 1858. It arose from a cestode worm, Hymenoleptis nana, lying in the sm
...
all colon of an Egyptian patient. He also discovered a trematode worm at the same time from an autopsy, thought to be the cause of urinary Schistosomiasis. Bilharz died from typhoid fever in 1862 at the age of 37. The Theodor Bilharz Research Institute in Giza, Egypt, stands as a tribute to him today. F. Milton published the first recorded peer-reviewed article report on Schistosomiasis in 1914.
more
Ethiopian Medicines Formulary
recommended
2nd edition
Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however, inaccuracies associated with current serological tests makes it difficu
...
lt to fully assess the need for and impact of eradication campaigns using these tools. Under the recommendation of the WHO Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases(NTDs), a working group was assembled and tasked with agreeing on priority use cases for developing target product profiles (TPPs) for new diagnostics tools.
more
WHO Prequalification of Diagnostics Programme -Public Report (Product: BD FACSPrestoTM Near-Patient CD4 Counter System, PQ number: PQDx 0197-045-00)
World Health Organization
(2016)
C_WHO
PQDx 0197-045-00 WHO
PQDx PR
March /2016, version 2.0
The development of this target product profile (TPP) was led by the WHO Department of Control of Neglected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to identify and prioritize diagnostic needs, a WHO NTD D
...
iagnostics Technical Advisory Group (DTAG) was formed, and different subgroups were created to advise on specific NTDs, including a subgroup working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of independent experts included leading scientists, public health officials and endemic-country end-user representatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of the available products and of the development pipeline was conducted, and the salient areas with unmet needs were identified.
more
WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: First Response® HIV 1-2-0 Card Test, Number: PQDx 0018-010-00)
World Health Organization
(2016)
C_WHO
PQDx 0018-010-00 WHO
PQDx PR
July/2016, version 3.0
In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive
...
predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
In March 2018, they convened a global meeting with the aim of establishing an action plan to develop new diagnostic solutions for Buruli ulcer and to create a framework of collaboration to address unmet needs in diagnostics for the disease. The participants agreed to develop a target product profile (TPP) to address the need for a rapid diagnostic test for use at the primary health-care level.
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WHO Prequalification of Diagnostics Programme - Public Report (Product: Alere DetermineTM HIV-1/2, Number: PQDx 0033-013-00)
World Health Organization
(2016)
C_WHO
PQDx 0033-013-00 WHO
PQ Public Report
July/2016, version 5.0
