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.

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!

21st December 2018 • 0 comments

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.

17th December 2018 • 0 comments

Protective parents and permissive children: what qualitative interviews with parents and children can tell us about the feasibility of juvenile idiopathic arthritis trials

by 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.

17th December 2018 • 0 comments

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 study

by 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.

17th December 2018 • 0 comments

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

by Carrol Gamble, Ashma Krishan, Deborah Stocken, Steff Lewis, Edmund Juszczak, Caroline Doré, Paula Williamson, Douglas G. Altman, Alan Montgomery, Pilar Lim, Jesse Berlin, Stephen Senn, Simon Day, Yolanda Barbachano, Elizabeth Loder

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.

4th December 2018 • 0 comments

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.

29th November 2018 • 0 comments

Development of an online resource for recruitment research in clinical trials to organise and map current literature

by 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. 

29th November 2018 • 1 comment

Including qualitative research in Randomized Controlled Trials (RCT): opportunities for nursing researchers

by 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.

6th November 2018 • 1 comment

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.

22nd October 2018 • 0 comments

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.

22nd October 2018 • 0 comments

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. 

22nd October 2018 • 0 comments

Performance of different clinical trial designs to evaluate treatments during an epidemic

by Matthias Brueckner, Andrew Titman, Thomas Jaki, Amanda Rojek, Peter Horby

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

17th October 2018 • 0 comments

Antimicrobial Resistance and Immunisation

by Authors: Sarah Bunn; Catherine Hall
17th October 2018 • 0 comments

Mental Health Awareness Month

by TGHN Editorial
7th September 2018 • 0 comments
15th August 2018 • comment