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The Research on Adverse Drug Events and Reports (RADAR) Project
Charles L. Bennett, MD, PhD, MPP;
Jonathan R. Nebeker, MS, MD;
E. Allison Lyons, BA;
Matthew H. Samore, MD;
Marc D. Feldman, MD;
June M. McKoy, MD, JD, MPH;
Kenneth R. Carson, MD;
Steven M. Belknap, MD;
Steven M. Trifilio, RPH;
Glen T. Schumock, PharmD, MBA;
Paul R. Yarnold, PhD;
Charles J. Davidson, MD;
Andrew M. Evens, DO;
Timothy M. Kuzel, MD;
Jorge P. Parada, MD, MPH;
Denis Cournoyer, MD;
Dennis P. West, PhD;
Oliver Sartor, MD;
Martin S. Tallman, MD;
Dennis W. Raisch, PhD
JAMA. 2005;293:2131-2140.
Context In 1998, a multidisciplinary team of investigators initiated RADAR (Research on Adverse Drug events And Reports), a clinically based postmarketing surveillance program that systematically investigates and disseminates information describing serious and previously unrecognized adverse drug and device reactions (ADRs).
Objective To describe the structure, operations, and preliminary findings from the RADAR project and related dissemination efforts by pharmaceutical suppliers and the US Food and Drug Administration (FDA).
Design After identifying a serious and unexpected clinical event suitable for further investigation, RADAR collaborators postulated clinical hypotheses and derived case series and incidence estimates from physician queries, published and unpublished clinical trials, published case reports, FDA databases, and manufacturer sales figures.
Results RADAR investigators identified 16 types of serious ADRs among 1699 patients, of whom 169 (10%) died as a result of the reaction. Initial cases were identified by 7 RADAR investigators, 4 collaborating physicians, 2 attorneys, and by reviewing 3 published reports. Additional sources included queries of occupational health programs and medical directors of interventional cardiology laboratories (3 types of ADRs), published manuscripts and clinical trials (11 types of ADRs), review of medical records at a RADAR site (2 types of ADRs), unpublished clinical trial reports (3 types of ADRs), and reports from attorneys, family members, or patients (4 types of ADRs). Incidence estimates, ranging from 0.4% to 33%, were derived from 5 clinical trial reports, 2 physician queries, and 2 observational databases. Laboratory support for hypotheses included identification of 3 neutralizing antibodies and 3 histopathological findings. ADR reports were disseminated as 8 revised package inserts, 7 "dear doctor" letters, and 9 peer-reviewed articles.
Conclusion A new, clinically based, hypothesis-driven approach to postmarketing surveillance may supplement existing regulatory surveillance systems and improve patient safety.
Author Affiliations: Jesse Brown VA Medical Center/Mid-West Center for Health Services and Policy Research, Chicago, Ill (Drs Bennett and Parada); Divisions of Hematology/Oncology (Ms Lyons, Drs Bennett, Carson, Evens, Kuzel, and Tallman), Division of Cardiology (Dr Davidson), Department of Emergency Medicine (Dr Yarnold), Division of General Internal Medicine (Dr Belknap), Division of Geriatric Medicine (Dr McKoy), Department of Dermatology (Dr West), Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, Ill (Drs Bennett, Carson, Evens, Kuzel, Tallman); Department of Pharmacy, Northwestern Memorial Hospital, Chicago, Ill (Mr Trifilio); Institute for Health Services Research and Policy Studies at Northwestern University, Evanston, Ill (Drs Carson and Bennett); Center for Pharmacoeconomic Research, College of Pharmacy, University of Illinois at Chicago, Chicago (Dr Schumock); San Antonio VA and the Department of Medicine at the University of Texas at San Antonio, San Antonio (Dr Feldman); VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, University of New Mexico, Albuquerque (Dr Raisch); University of Utah School of Medicine and the Salt Lake City VA, Salt Lake City (Drs Nebeker and Samore); Departments of Medicine and Oncology, McGill University, Montreal, Canada (Dr Cournoyer); Stanley Scott Cancer Center and the Divisions of Hematology/Oncology of the Louisiana State University School of Medicine, New Orleans (Dr Sartor).
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