Pooling Different Safety Data Sources: Impact of Combining Solicited and Spontaneous Reports on Signal Detection In Pharmacovigilance.
Jeremy D JokinenRosalind J WalleyMichael W ColopyThomas S HilzingerPeter VerdruPublished in: Drug safety (2020)
This analysis of simulated data suggests that pooling AE data from solicited sources with spontaneous case data may impact the results of disproportionality analyses, masking true safety signals and identifying false positives. Therefore, increased volumes of safety data do not necessarily correlate with improved safety signal detection.