Webinar: Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response, 5 March 2019by The Editorial Team
Engagement Strategies: The Development of Mahidol Oxford Tropical Medicine Research Unit’s (MORU) Community and Stakeholder Engagement Strategyby Phaik Yeong Cheah, Mesh Editorial Team
Neurodevelopmental milestones and associated behaviours are similar among healthy children across diverse geographical locationsby INTERGROWTH-21st
The latest findings from the international INTERGROWTH-21st Project, that has monitored healthy, urban children from educated families across four continents from early pregnancy to 2 years of age, show that human neurodevelopment is not influenced by the colour of an individual’s skin.
Several of Global Health Trials' Regional Faculties have implemented exceptional, cost-effective blended learning schemes, using a computer room and the Global Health Network's free eLearning courses to create a novel way of building their research teams' skills and knowledge. The Nigerian faculty explain their experiences here, and you can download their "how to" document on the right hand side of the screen, to use at your own site!
While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility. Recommendations are provided for a minimum set of items that should be addressed and included in SAPs for clinical trials. Trial registration, protocols, and statistical analysis plans are critically important in ensuring appropriate reporting of clinical trials.
ORRCA (www.orrca.org.uk) is a free, online, searchable database of research around recruitment to Clinical Trials. It aims to help users identify promising recruitment interventions and inform the matching or tailoring of these interventions to specific recruitment challenges faced by different types of trial.
Development of an online resource for recruitment research in clinical trials to organise and map current literatureby Anna Kearney, Nicola Harman, Anna Rosala-Hallas, Claire Beecher, Jane Blazeby, Peter Bower, Mike Clarke, William Cragg, Sinead Dune, Heidi Gardner, Patricia Healy, Lisa Maguire, Nicola Mills, Leila Rooshenas, Ceri Rowlands, Shaun Treweek, Akke Vellinga, Paula Williamson, Carrol Gamble
Transparency in the conduct and reporting of clinical trials is supported by the guidance produced on the content of clinical trial protocols and reporting standards for clinical trials. While the principle features of the statistical analysis are required within this guidance it is generally accepted that a separate Statistical Analysis Plan is also developed as the level of detail appropriate for a SAP is excessive for a protocol. However, there is no detailed guidance on the content of a SAP and consequently, there is marked variation in practice.
The workshop was attended by 120 total participants over two days, and here we provide a report of the workshop, as well as all the presentations from the day.
In the 2013-2016 west Africa outbreak of Ebola Virus Disease (EVD), most of the planned clinical trials failed to reach a conclusion within the time frame of the epidemic. We conduct a comprehensive evaluation of commonly used two- and multi-arm clinical trial designs based on real data, which was recorded during the 2013-16 EVD epidemic in west Africa
Summary of two-day international workshop on new challenges in research ethics in Lima, Peru, August 2018by REDe
Participate in Doctors Without Borders (MSF) survey on the value of sharing medical case reports from humanitarian and resource limited settingsby The Editorial Team
REPORT OF THE 2018 ONE DAY FREE WORKSHOP ON CLINICAL RESEARCH CAPACITY BUILDING FOR CLINICAL RESEARCH IN NIGERIAby Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead, morenike Ukpong, AUGUSTINE ONYEAGHALA - Senior Contributor, ogundokun Olusegun - Senior Contributor, Regional Faculty Committee Member, Ekezie Ralueke Oluchukwu
This report details the workshop held on 7th July 2018 at the Nigerian Airforce Conference Centre, Abuja.
This Guide to Efficient Trial Management, published by the Trial Manager's Network (UK) and available freely online, is a must for all trial managers or coordinators. This link is for the 6th Edition (2018)
Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopiaby Meseret Molla, Henok Negussie, Moses Ngari, Esther Kivaya, Patricia Njuguna, Fikre Enqueselassie, James A. Berkley, Gail Davey
We use the example of the Gojjam Lymphoedema Best Practice Trial (GoLBeT), a pragmatic trial in a remote rural setting in northern Ethiopia, to extract lessons relevant to other investigators balancing the demands of practicality and community acceptability with internal and external validity in clinical trials.