Performance of the Self‐Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink ( <scp>CPRD</scp> )
Using a carefully designed reference set of drug-outcome pairs well suited to the study design, the SCCS performed moderately well for signal detection in CPRD. Whilst active comparators effectively reduced confounding by indication, they also reduced the number of correctly identified positive controls, due to a reduction in power. We showed some evidence that SCCS is able to highlight SDRs before they were present on labels.
Authors
- Andrew Bate (ORCID: https://orcid.org/0000-0003-3151-3653)
- Angel Y. S. Wong (ORCID: https://orcid.org/0000-0002-8618-7333)
- François Haguinet (ORCID: https://orcid.org/0000-0003-4989-3738)
- Ian Douglas (ORCID: https://orcid.org/0000-0002-8970-1406)
- Astrid Coste (ORCID: https://orcid.org/0000-0003-4207-7447)
Institutions
- London School of Hygiene & Tropical Medicine (GB)
- GlaxoSmithKline (Belgium) (BE)
- Center for Non-Communicable Diseases (PK)
Publication Details
- Journal
- Pharmacoepidemiology and Drug Safety
- Published
- 2025-12-01
- DOI
- https://doi.org/10.1002/pds.70243
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- GlaxoSmithKline