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