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Publication Years
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Document No. : FDA/SMC/CTD/GL-CCT/2013/01
Optimizing Clinical Trial Design to Maximize Evidence Generation in Pediatric HIV
D. Ford; R. Turner; A. Turkova; et al.
JAIDS Journal of Acquired Immune Deficiency Syndromes; Ovid
(2018)
C2
Supplement Article
www.jaids.com J Acquir Immune Defic Syndr Volume 78, Supplement 1, August 15, 2018
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
...
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.
more
Despite recent global declines, under-five mortality remains high in many of the poorest countries. Barriers to timely
quality care, including user fees, distance to facilities and the availability of trained health workers and medical supplies,
hinder progress in further reducing morbidity and m
...
ortality
more
the Lancet : Published Online July 31, 2015 http://dx.doi.org/10.1016/S0140-6736(15)61117-5
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
...
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
more
The Lancet. Published Online December 22, 2016 http://dx.doi.org/10.1016/S0140-6736(16)32621-6. Open Access
BMC Medicine (2015) 13:42 DOI 10.1186/s12916-014-0263-6
PLoS Med 16(3): e1002768. https://doi.org/10.1371/journal.pmed.1002768
Home delivery and late and infrequent attendance at antenatal care (ANC) are responsible for substantial avoidable maternal and pediatric morbidity and mortality in sub-Saharan Africa. This cluster-randomized
...
trial aimed to determine the impact of a community health worker (CHW) intervention on the proportion of women who visit ANC fewer than 4 times during their pregnancy and deliver at home.
more
Solidarity” is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners.
The Solidarity Trial will compare four t
...
reatment options against standard of care, to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity Trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence.
Until there is sufficient evidence, WHO cautions against physicians and medical associations recommending or administering these unproven treatments to patients with COVID-19 or people self-medicating with them. WHO is concerned by reports of individuals self-medicating with chloroquine and causing themselves serious harm.
more
Trials (2017) 18:152, DOI 10.1186/s13063-017-1881-z
Published:February 02, 2021DOI:https://doi.org/10.1016/S0140-6736(21)00234-8
PLOS ONE | https://doi.org/10.1371/journal.pone.0196239 April 23, 2018
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
...
tudy aimed to test both interventions in low-income and middle-income countries.
more
Trials (2018) 19:271 https://doi.org/10.1186/s13063-018-2604-9
Based on the findings of this trial, we will examine the potential use and scale up of iSupport for caregiver distress in India. This style of online self-help programs could be expande
...
d to other regions or countries or to other suitable caregiver groups
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.
