Why Adverse Events Go Unreported in Clinical Trials

DarshanTalks Podcast - A podcast by Darshan Kulkarni

In clinical trials, reporting adverse events and protocol deviations is crucial for patient safety and trial integrity. However, some sites may hesitate to report due to concerns about trial disruption, revenue loss, and increased scrutiny. This reluctance can lead to serious consequences, as seen in cases where significant events like hives, disruptions in menstrual cycles, violent episodes, or even deaths were not reported. While some cases were eventually identified, others went unnoticed,...