title: Results from the first decade of research conducted by the Research on Adverse Drug Events and Reports (RADAR) project.
abstract: BACKGROUND
  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suitable for further investigation, RADAR collaborators derived case information from physician queries, published and unpublished clinical trials, case reports, US FDA databases and manufacturer sales figures.
  
  
  METHODS
  All major RADAR publications from 1998 to the present are included in this analysis.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  An independent National Institutes of Health-funded post-marketing surveillance programme can supplement existing regulatory and pharmaceutical manufacturer-supported drug safety initiatives.
authors.affiliation: The Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. j-mckoy@northwestern.edu
authors.forename: June M
authors.initials: JM
authors.lastname: McKoy
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Fisher
authors.forename: D Mark
authors.initials: DM
authors.lastname: Courtney
authors.forename: Dennis W
authors.initials: DW
authors.lastname: Raisch
authors.forename: Beatrice J
authors.initials: BJ
authors.lastname: Edwards
authors.forename: Marc H
authors.initials: MH
authors.lastname: Scheetz
authors.forename: Steven M
authors.initials: SM
authors.lastname: Belknap
authors.forename: Steven M
authors.initials: SM
authors.lastname: Trifilio
authors.forename: Athena T
authors.initials: AT
authors.lastname: Samaras
authors.forename: Dustin B
authors.initials: DB
authors.lastname: Liebling
authors.forename: Beatrice
authors.initials: B
authors.lastname: Nardone
authors.forename: Katrina Marie
authors.initials: KM
authors.lastname: Tulas
authors.forename: Dennis P
authors.initials: DP
authors.lastname: West
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends*; D002986:Clinical Trials as Topic / Q000379:methods / Q000639:trends; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration / Q000639:trends*
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