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The conduct of COVID-19 vaccine trials in the context of a candidate vaccine being issued with Emergency Use Designation raises challenging ethical questions, including in relation to the use of placebo controls and unblinding of trial participants
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in current and future COVID-19 vaccine trials. This policy brief was developed by the WHO Access to COVID-19 Tools (ACT) Accelerator Ethics & Governance Working Group, to provide guidance for researchers, sponsors, regulators, research ethics committees, and policy-makers, on these and related issues.
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Published:February 02, 2021DOI:https://doi.org/10.1016/S0140-6736(21)00234-8
Soil-transmitted helminths (STH) affect 1.45 billion people worldwide, and high intensity infections are associated with anemia, undernutrition and impaired cognition, particularly among children. Mathematical models suggest it may be possible to interrupt the transmission of STH in a community by e
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xpanding mass drug administration (MDA) from targeted high-risk groups (primarily school-aged children and women of child-bearing age) to all community members with high coverage. The DeWorm3 Project will test the feasibility of this approach to interrupting the transmission of STH using a series of cluster randomized trials in Benin, India and Malawi. Each study area (population 80,000) will be divided into 40 clusters and randomized to community-wide or standard-of-care targeted MDA for three years. Two years following the final round of MDA, prevalence of STH will be compared between arms and transmission interruption assessed in each cluster. The DeWorm3 trials will provide stakeholders with information regarding the potential to switch from STH control to a more ambitious and sustainable strategy.
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The Lancet, Early Online Publication, 11 July 2014
doi:10.1016/S0140-6736(14)60934-X
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The Lancet. Published Online December 22, 2016 http://dx.doi.org/10.1016/S0140-6736(16)32621-6. Open Access
Surgical site infection (SSI) is the most common postoperative complication worldwide. WHO guidelines to prevent SSI recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures, but called for assessment of both interventions in low-resource settings. This s
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tudy aimed to test both interventions in low-income and middle-income countries.
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The Lancet Vol.400 (2022) p.17-67-1776. Published:October 31, 2022DOI:https://doi.org/10.1016/S0140-6736(22)01884-0.
Surgical site infection (SSI) is the most common complication of surgery around the world: ChEETAh trial finds routinely changing g
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loves and instruments for wound closure could prevent as many as one in eight SSIs in abdominal surgery
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita
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ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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Lancet Infectious Disease Volume 24, Issue 4p386-394April 2024
Lancet 2024; 403: 533–44
R21/Matrix-M was well tolerated and offered high efficacy against clinical malaria in African children. This
low-cost, high-efficacy vaccine is already licensed by several African countries, and recently received a WHO policy
recommendation and prequalification, offerin
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g large-scale supply to help reduce the great burden of malaria in sub-
Saharan Africa.
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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
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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
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Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE)
Researchers are devising a clinical-trial protocol to test three medicines in Africa's latest outbreak
Nature doi: 10.1038/d41586-018-06132-7
The results of the SHINE trial have been published in the NEJM today. SHINE looked at whether treatment for children with minimal TB could be reduced from 6 months to 4 months. It found that the four month treatment was as good as the standard six m
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onths treatment for children with minimal TB
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A post-hoc instrumental variable-based analysis of a cluster randomized trial in Eldoret, Kenya. Front. Public Health, 05 May 2023
Sec. Public Mental Health Volume 11 - 2023 | https://doi.org/10.3389/fpubh.2023.1150744
Learn what scientists look for in the different phases of a clinical trial for a vaccine. What does it mean when a vaccine trial is halted due to an adverse event? WHO’s Dr Kate O’Brien explains
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in Science in 5 this week
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Phillips and colleagues have shown that rifampicin combined with clarithromycin is non-inferior to RS8, and is safer. This much anticipated trial provides us with a high degree of confidence that an 8-week course of oral rifampicin and clarithromyci
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n should now be the cornerstone of the treatment of Buruli ulcer everywhere. However, this finding does not mean that
Buruli ulcer is cured at 8 weeks.
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This report examines how clinical trials contribute to environmental impacts and outlines key considerations for integrating environmental sustainability into trial design, conduct and oversight. It explores the carbon footprint and resource use ass
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ociated with clinical research activities – including site operations, participant travel, supply chains, data management and waste – and highlights how these impacts intersect with climate change risks to health systems and research infrastructure.
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