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.

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 • comment

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 • comment

These recommendations are intended as a tool to help research staff and community representatives expand and deepen existing partnerships, and forge new ones, with the ultimate goal of facilitating effective community engagement in all aspects of clinical trials research.

4th April 2016 • comment

An overview on trial registration. Here you can find out why trials need to be registered and what the difference is between all the registries - and how to register your study.

1st November 2010 • comment