The aims of RADAR are to disseminate safety reports for serious adverse drug reactions and to identify barriers to identification and reporting of these events. Investigators have developed a well-coordinated system to accurately compile case report information on sADRs and to identify milestones associated with identification and reporting of the relevant ADR information. This ADR identification system allows us to amass pertinent sADR information from a diverse set of data sources in order to identify and report sADRs in a timely and thorough manner. The RADAR methodology relies on initial recognition of these "sentinel" cases that then prompts hypothesis-driven inquiries as to whether an unrecognized adverse drug event signal is present in the patients exposed to that drug. Hypothesis-driven active surveillance of small but thorough sets of safety reports serves as the underlying conceptual framework of RADAR pharmacovigilance. Fewer than 20 individual ADR reports led to RADAR investigators identifying safety signals for the majority of the ADRs described to date.The success of the RADAR program has been largely based on the use of diverse data sources to identify, clarify, and verify ADRs.
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).
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postulated clinical hypotheses and derived case series and incidence estimates from physician queries, published and unpublished clinical trials, published case reports, FDA databases, and manufacturer sales figures.
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manuscripts and clinical trials (11 types of ADRs), review of medical records at a RADAR site (2 types of ADRs), unpublished clinical trial reports (3 types of ADRs), and reports from attorneys, family members, or patients (4 types of ADRs).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.
RADAR Informatics / Drug Safety
- David A. Dorr, MD, MS
- Dennis W. Raisch PhD, RPh, MS
- Paul R. Yarnold, PhD
- Jonathan Nebeker, MD, MS
- Denys T. Lau, PhD
- Steve Trifilio, RPh
RADAR Emergency Medicine
RADAR Infectious Disease
RADAR Oncology
RADAR Informatics / Dermatology
RADAR Geriatrics/FDA Oversight
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