Keywords: AE reporting with exposure time, multiple events
In clinical trials, it is desirable for the sponsors to provide accurate, unbiased and comprehensive AE reports that allow the regulatory agencies, physicians and patients to have a better understanding of the safety information. In this roundtable, we will discuss different ways of improving AEs reporting in the clinical study reports and regulatory submissions. The discussion will focus on a few important aspects of AE reporting, including AE incidence rate while the overall exposure time of safety population is considered, time to the events, duration and multiple occurrences of adverse events. We will also explore a way to characterize dose-response with regards to AE reports.
Questions: • What more can be done in the protocol, CRF and SAP, to allow more meaningful analysis of AE data? • What can we do to make the AE incident rate report less biased when subjects have different exposure in the studies?