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Erschienen in:
01.05.2013 | Original Research Article
Results from the First Decade of Research Conducted by the Research on Adverse Drug Events and Reports (RADAR) Project
Erschienen in: Drug Safety | Ausgabe 5/2013
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Introduction
In 1998, a multidisciplinary team of investigators initiated the Research on Adverse Drug events And Reports (RADAR) project, a post-marketing surveillance effort that systematically investigates and disseminates information describing serious and previously unrecognized serious adverse drug and device reactions (sADRs).
Objective
Herein, we describe the findings, dissemination efforts, and lessons learned from the first decade of the RADAR project.
Methods
After identifying serious and unexpected clinical events suitable for further investigation, RADAR collaborators derived case information from physician queries, published and unpublished clinical trials, case reports, US FDA databases and manufacturer sales figures.
Study selection
All major RADAR publications from 1998 to the present are included in this analysis.
Data extraction
For each RADAR publication, data were abstracted on data source, correlative basic science findings, dissemination and resultant safety information.
Results
RADAR investigators reported 43 serious ADRs. Data sources included case reports (17 sADRs), registries (5 sADRs), referral centers (8 sADRs) and clinical trial reports (13 sADRs). Correlative basic science findings were reported for ten sADRs. Thirty-seven sADRS were described as published case reports (5 sADRs) or published case-series (32 sADRs). Related safety information was disseminated as warnings or boxed warnings in the package insert (17 sADRs) and/or ‘Dear Healthcare Professional’ letters (14 sADRs).
Conclusion
An independent National Institutes of Health-funded post-marketing surveillance programme can supplement existing regulatory and pharmaceutical manufacturer-supported drug safety initiatives.