Signal Detection & Analysis Flashcards
7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Signal Detection & Analysis flashcards as text
Which statistical measure is used in Empirical Bayes Geometric Mean (EBGM) signal detection to shrink estimates toward the prior mean?
Answer: Bayesian shrinkage toward the global reporting rate
EBGM applies Bayesian shrinkage that pulls individual drug-event estimates toward the overall reporting rate when observed counts are low, reducing noise.
In the context of signal detection, what is the primary risk of using a very low minimum threshold (e.g., N≥1) for reporting count?
Answer: Excessive false-positive signals from sparse data instability
Very low count thresholds produce unstable, noisy signals dominated by chance associations rather than true pharmacovigilance signals.
When a signal is detected in spontaneous reporting data, what is the MOST important next step before escalating to a formal safety review?
Answer: Signal validation to confirm the association is not an artifact
Signal validation involves assessing whether a detected disproportionality reflects a true biological association or is due to confounding, data quality issues, or statistical artifact.
Which of the following is a recognized limitation of spontaneous reporting systems (SRS) that directly impacts signal detection sensitivity?
Answer: Unknown denominator and underreporting of adverse events
SRS lack a defined denominator (exposed population) and suffer from significant underreporting, making true incidence rates impossible to calculate directly.
What is 'masking' (or 'competition bias') in the context of pharmacovigilance signal detection?
Answer: A true signal for one drug-event pair is suppressed by a stronger signal from another drug for the same event
Masking occurs when a strong signal for one drug-event combination reduces the apparent disproportionality for another drug-event pair in the same database.
In MedDRA hierarchy, which level is most commonly used as the unit of analysis in disproportionality signal detection?
Answer: Preferred Term (PT)
Preferred Terms are the primary analysis level for signal detection because they represent distinct medical concepts with sufficient granularity and coding consistency.
Which approach helps address the problem of time-to-onset variability when analyzing signals for drug-induced liver injury (DILI)?
Answer: Restricting the analysis window to reports with onset within a clinically plausible latency period
Restricting to biologically plausible latency windows improves signal specificity by excluding temporally implausible associations for DILI.