Exploring Completeness of Adverse Event Reports as a Tool for Signal Detection in Pharmacovigilance.
Inyoung LeeJeremy D JokinenStephanie Y CrawfordGregory Sampang CalipRyan D KilpatrickTodd A LeePublished in: Therapeutic innovation & regulatory science (2020)
Completeness of AE reports did not significantly impact the ability to detect signals when weighting by vigiGrade score or restricting the database based on the level of completeness. While the vigiGrade helps provide quality assessments of AE reports and prioritize cases for review, our findings indicate the tool might not be useful for quantitative signal detection when used by itself.