Abstract:
Stephen Senn writes, "much of the statistical theory of planning clinical trials has to do with investigating efficacy rather than safety". In fact, the analysis of adverse events (AEs) in randomised controlled trials (RCTs) has been neglected and accepted good analysis practice is often disregarded. There is an understanding within the clinical trials community that how we analyse and report AEs in RCTs needs to change. Efforts are being made, but these are overwhelming driven by industry with a focus on the analysis of prespecified harm outcomes, with little attention given to the analysis of emerging harms i.e., those events that are not defined at the outset but are obtained from reports throughout the study (i.e. the AEs).

In this talk I will provide an overview of current practice for the analysis of AEs in RCTs. I will demonstrate how a well-designed graphic can be a highly effective means to summarise harm profiles and identify potential adverse reactions. I will also outline our current work to promote the use of accepted good practice principled analysis approaches when analysing harm outcomes in RCTs and summarise our public involvement activities which have informed our work on communication of potential intervention harm.