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Document No. : FDA/SMC/CTD/GL-CCT/2013/01
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 associated 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.
more
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.
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
A Guide For Multicentre Trials in High-Burden Countries
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 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 months treatment for children with minimal TB
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 in Science in 5 this week
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
Pregnancy often results in exclusion from clinical trials of antiretroviral (ARV) drugs, resulting in limited data on pharmacokinetics (PK), drug safety, and the efficacy of new ARV drugs in pregnan
...
cy and lactation. However, pregnancy, lactation, or the potential for pregnancy should not preclude the use of drug regimens that would be chosen for people who are not pregnant, unless adequate drug levels are not likely to be attained in pregnancy or known adverse effects outweigh potential benefits
more
A living WHO guideline on drugs for covid-19
recommended
BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3379
Rapid Recommendation and visual graph. This is the fifth version (update 4) of the living guideline (BMJ 2020;370:m3379). When citing this article, please consider adding the update number and date of access for clarity. The publication of the RE
...
COVERY and REMAP-CAP randomised controlled trials triggered this guideline update, resulting in a strong recommendation for interleukin-6 (IL-6) receptor blockers (tocilizumab or sarilumab) in patients with severe or critical covid-19.
Prior recommendations: (a) A recommendation not to use ivermectin in patients with covid-19, regardless of disease severity, except in the context of a clinical trial; (b) a strong recommendation against the use of hydroxychloroquine in patients with covid-19, regardless of disease severity; (c) a strong recommendation against the use of lopinavir-ritonavir in patients with covid-19, regardless of disease severity; (d) a strong recommendation for systemic corticosteroids in patients with severe and critical covid-19; (e) a conditional recommendation against systemic corticosteroids in patients with non-severe covid-19; and (f) a conditional recommendation against remdesivir in hospitalised patients with covid-19.
more
New Drugs for Human African Trypanosomiasis: A Twenty First Century Success Story
Dickie, E.A.; Giordani, F.; Gould, M.K.; Mäser, P.; Burri, C.; Mottram, J.C.; Rao, S.P.S.; Barrett, M.P.
MDPI Tropical Medicine and Infectious Disease
(2020)
CC2
The twentieth century ended with human African trypanosomiasis (HAT) epidemics raging across many parts of Africa. Resistance to existing drugs was emerging, and many programs aiming to contain the disease had ground to a halt, given previous success against HAT and the competing priorities associat
...
ed with other medical crises ravaging the continent. A series of dedicated interventions and the introduction of innovative routes to develop drugs, involving Product Development Partnerships, has led to a dramatic turnaround in the fight against HAT caused by Trypanosoma brucei gambiense. The World Health Organization have been able to optimize the use of existing tools to monitor and intervene in the disease. A promising new oral medication for stage 1 HAT, pafuramidine maleate, ultimately failed due to unforeseen toxicity issues. However, the clinical trials for this compound demonstrated the possibility of conducting such trials in the resource-poor settings of rural Africa.
more
This issue brief provides information about TB and HIV clinical trials and research programs
impacted by U.S. government funding disruptions, and proposes urgent actions that
donor agencies, gover
...
nments, and philanthropies can take to preserve scientific advances
underway and prevent the collapse of TB and HIV medical research in South Africa
more
Background
The core clinical symptoms of addiction include an enhanced incentive for drug taking (craving), impaired self-control (impulsivity and compulsivity), emotional dysregulation (negative mood) and increased stress reactivity. Symptoms rela
...
ted to impaired self-control involve reduced activity in anterior cingulate cortex (ACC), adjacent prefrontal cortex (mPFC) and other brain areas. Behavioral training such as mindfulness meditation can increase the function of control networks including those leading to improved emotion regulation and thus may be a promising approach for the treatment of addiction.
Methods
In a series of randomized controlled trials (RCTs), we tested whether increased ACC/mPFC activity is related to better self-control abilities in executive functions, emotion regulation and stress response in healthy and addicted populations. After a brief mindfulness training (Integrative Body-Mind Training, IBMT), we used the Positive and Negative Affect Schedule (PANAS) and Profile of Mood States (POMS) to measure emotion regulation, salivary cortisol for the stress response and fMRI for brain functional and DTI structural changes. Relaxation training was used to serve as an active control.
Results
In both smokers and nonsmokers, improved self-control abilities in emotion regulation and stress reduction were found after training and these changes were related to increased ACC/mPFC activity following training. Compared with nonsmokers, smokers showed reduced ACC/mPFC activity in the self-control network before training, and these deficits were ameliorated after training.
Conclusions
These results indicate that promoting emotion regulation and improving ACC/mPFC brain activity can help for addiction prevention and treatment.
more
May 9, 2022.Since the onset of the COVID-19 pandemic, a large number of clinical trials have been planned and developed to assess the effectiveness and safety of various interventions that could pre
...
vent hospitalizations and progression to severe disease in people infected with SARS-CoV-2. Currently, the WHO and the PAHO recommend the use of corticosteroids, tocilizumab, baricitinib, and casirivimab e imdevimab (the latter in seronegative COVID-19 patients) and propose the use of sotrovimab, casirivimab/imdevimab, and molnupiravir in patients with non-severe illness who are at high risk for complications
more
