Clinical characterization of mpox including monitoring the use of therapeutic interventions: statistical analysis plan, April 2025

Overview

This document describes how the data from the WHO Global Clinical Platform will be statistically handled. The reports generated and published from the proposed analyses will help clinicians and national programs to optimize management and response strategies. 

Updates to the previous version of this statistical analysis plan (published October 2023) include: more information on data sources; subsections on the contribution of data to the data platform and participants’ inclusion criteria; enhanced detail on study design; updated sample size justification and calculation; expanded detail on variables and their definitions (both outcome and exposure/ confounders). Specifically for the statistical analysis the new version includes more information on the type of summary and inferential analyses that may be required for each objective, and on the treatment of missing data. All dummy tables have been modified with extra information included.