These guidance articles are peer reviewed and provided to give research teams high quality and trustworthy information on how to conduct a task or resolve an issue in the design, conduct or reporting of a clinical trial. Articles are accompanied by resources, such as a template or example documents. These are free for you to download and adapt for your study. Please acknowledge www.globalhealthtrials.org if you use these.
Survey launched to understand clinical and research impact of INTERGROWTH-21st tools after 120,000 downloadsby The Editorial Team
Webinar: Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response, 5 March 2019by The 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.
Applications open for course on epidemiological evaluation of vaccines: efficacy, safety and policy (1-12 July 2019)by The Editorial Team
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!
The value of an embedded qualitative study in a trial of a second antidepressant for people who had not responded to one antidepressant: understanding the perspectives of patients and practititionersby Carolyn A. Chew-Graham, Thomas Shepherd, Heather Burroughs, Katie Dixon, David Kessler
We report a qualitative study embedded in a trial of second antidepressant for people who had not responded to one antidepressant, exploring the acceptability of a combination of antidepressants from the perspectives of both patients and practitioners, together with experiences of participating in a clinical trial.
Protective parents and permissive children: what qualitative interviews with parents and children can tell us about the feasibility of juvenile idiopathic arthritis trialsby Frances C. Sherratt, Louise Roper, Simon R. Stones, Flora McErlane, Matthew Peak, Michael W. Beresford, Helen Foster, Athimalaipet V. Ramanan, Madeleine Rooney, Eileen Baildam, Bridget Young
Studies involving CYP are advocated in the literature but we are not aware of any early stage feasibility studies that have qualitatively accessed the perspectives of parents and CYP with a long term condition to inform design and conduct of a trial. In the context of a feasibility study to inform the design of a proposed randomised controlled trial of corticosteroid induction regimen in JIA, we explored families’ perspectives on the proposed trial and on JIA trials generally.
Nurses’ perceptions towards the delivery and feasibility of a behaviour change intervention to enhance activity in patients at risk for cardiovascular disease in primary care: a qualitative studyby Heleen Westland, Yvonne Koop, Carin D. Schröder, Marieke J. Schuurmans, P. Slabbers, Jaap C. A. Trappenburg, Sigrid C. J. M. Vervoort
This study aimed to evaluate nurses’ perceptions towards the delivery and feasibility of the Activate intervention.
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.
Including qualitative research in Randomized Controlled Trials (RCT): opportunities for nursing researchersby Loredana Sasso, Mark Hayter, Gianluca Catania, Giuseppe Aleo, Milko P Zanini , Annamaria Bagnasco
n this editorial we argue that qualitative research can enhance the quality, rigor and depth of an RCT –but at present this is an opportunity that is frequently missed. We further propose that not only can qualitative research enhance the design and conduct of an RCT it also provides an opportunity for qualitative researchers (often nurse researchers) and research nurses (often not actively involved in undertaking research) to work with medical colleagues to improve the quality of RCT design.
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.
This page provides links to commonly used reporting guidelines for qualitative research, as well as articles which provide useful information about how to write about your research.
This paper provides a general guide to presenting qualitative research for publication in a way that has meaning for authors and readers, is acceptable to editors and reviewers, and meets criteria for high standards of qualitative research reporting across the board. We discuss the writing of all sections of an article, placing particular emphasis on how you might best present your findings, illustrating our points with examples drawn from previous issues of this Journal.
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