Uncommon things commonly occur: how best to handle 1000's of SAEs

Large clinical trials conducted in populations of unwell people can accrue many thousands of serious adverse events regardless of the effects of agents under test. The same may be true when multiple smaller studies are aggregated across a full clinical development programme.  This poses difficulties for Data and Safety Monitoring Boards and study sponsors, both of which have a responsibility to review data to enable early detection of safety issues to safeguard study participants. This presentation, from an industry trial-sponsor’s perspective, will discuss how making better use of hierarchical coding, graphical displays and other techniques can help those responsible for study oversight distinguish the wood from the trees.