Several challenges can impact the effectiveness of safety monitoring: - Underreporting: Not all adverse events are reported, leading to incomplete data. - Data Quality: Variability in how data is collected and reported can affect the accuracy of findings. - Signal Detection: Distinguishing true safety signals from background noise in the data can be complex. - Timeliness: Rapid identification and response to safety concerns are crucial but can be hindered by delays in data collection and analysis.
