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Signal detection in spontaneous reporting can be challenging
For post-market surveillance, spontaneous reports of adverse events are a core source of information.
They offer a unique, unrestricted perspective on drug performance. However, their effective use of data from spontaneous reporting systems is complicated by information heterogeneity and biases in report submissions that hamper signal detection. In order to leverage the full value of databases like FAERS, VigiBase and EudraVigilance, signal detection must be enhanced and guided with knowledge integrated across multiple sources.
In this white paper, you will learn more about:
- How spontaneous reporting is the cornerstone of signal detection
- The limitations of data-mining in spontaneous report databases
- How important signals may be masked — and appear insignificant