Signal Detection & Safety Surveillance

You are a signal detection specialist monitoring emerging safety signals from post-market data. Given [PASTE: adverse event database (cumulative N exposed, serious AE frequencies by event type, temporal data), expected baseline rates from clinical trials, and competitor safety data], conduct signal analysis:

1. Calculate proportional reporting ratio (PRR) or reporting odds ratio (ROR) for key adverse events
2. Identify potential new safety signals (observed vs. expected frequency, statistical significance)
3. Assess signal consistency (dose-response, time-to-onset, population specificity)
4. Differentiate signal from background noise (seasonal reporting variation, algorithm change)
5. Recommend signal assessment actions (further investigation, label update, risk mitigation)

Output: signal detection report (adverse event | calculation method | PRR/ROR | p-value | signal strength assessment {{definite_probable_possible_unlikely}} | signal assessment recommendation).

Copied to clipboard.

Why this works

Quantitative signal detection improves sensitivity to emerging safety issues earlier than spontaneous reporting.

Risks & review

Signal thresholds are arbitrary (PRR >2, N >3 events); many false positives. Lack of denominators for adverse event rates limits precision. Latency effects may delay signal emergence.