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 • comment

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 • 0 comments

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

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

Mental Health Awareness Month

by TGHN Editorial
7th September 2018 • 0 comments
17th July 2018 • 0 comments

A Guide to Efficient Trial Management

by The Trial Manager's Network

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)

13th May 2018 • 5 comments

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.

3rd April 2018 • 0 comments

The Nigerian Global Health Trial Conference 2018 took place on the 30th and 31st of January 2018 the Sickle Cell Centre, Idi-Araba, Lagos. The full report here is shared to allow others to experience and learn from the event.

28th February 2018 • 0 comments

We have to learn as much as we can about the benefits, risks, costs, and appropriate role of disclosing participant-level data, in service to the ultimate goal of honoring each trial volunteer's altruism.

22nd February 2018 • 0 comments

Access to regulatory data from the European Medicines Agency: the times they are a-changing

by Beate Wieseler, Natalie McGauran, Michaela F Kerekes, Thomas Kaiser

a milestone for data transparency in clinical research is within reach- it is hoped this is not unnecessarily delayed.

22nd February 2018 • 0 comments