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Introducing RADAR: The Research on Adverse Drug Events And Reports (RADAR) Project

Introducing RADAR: The Research on Adverse Drug Events And Reports (RADAR) Project. Charles L. Bennett MD, PhD, MPP Feinberg School of Medicine, Northwestern University Midwest Center for Health Services and Policy Research. ADR Definition.

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Introducing RADAR: The Research on Adverse Drug Events And Reports (RADAR) Project

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  1. Introducing RADAR: The Research on Adverse Drug Events And Reports (RADAR) Project Charles L. Bennett MD, PhD, MPP Feinberg School of Medicine, Northwestern University Midwest Center for Health Services and Policy Research

  2. ADR Definition • “Drug or device-associated ADR that results in death, severe organ failure, or precipitates major therapeutic interventions” • Ex. cardiopulmonary resuscitation, intubation and mechanical ventilation, plasmapheresis, frequent transfusion of blood or blood products, or organ transplantation [32] • Prolonged hospitalization not included

  3. Reasons for RADAR • ADRs account for 100,000 deaths annually • > half 45 ADRs associated with BB identified >7 yrs following FDA approval • Size of many licensing clinical trials is too small to identify rare but serious ADRs • MedWatch many limitations

  4. RADAR Purpose • Evaluates initial reports of previously unrecognized but serious ADRs • Identifies additional reports of each ADR • Develops hypotheses for mechanistic pathways • Evaluates related laboratory and pathologic findings • Derives reporting and incidence rate estimates

  5. RADAR Grant Support • National Heart, Lung, and Blood Institute • National Cancer Institute • American Cancer Society • Department of Veterans Affairs • Pharmaceutical companies have not financed this project in any manner

  6. RADAR Members • 25 core investigators • Internal Medicine (geriatrics, cardiology, infectious disease, neurology, dermatology, hematology, oncology) • Pharmacology • Epidemiology • Statistics • Pharmacy

  7. Investigator Contact • Weekly conference calls that includes RADAR members located in the Chicago area and those around the globe • Meeting minutes and agendas are circulated based on these calls

  8. RADAR Dissemination • Medical journals • Revised package insert • “Dear Doctor” letters • National medical conferences • Meetings with the FDA • Meetings with Pharmaceutical company representatives

  9. ADR Investigation Flow

  10. Reporting Rates/Incidence Rates • Reporting Rates • numbers of identified cases of the particular event / total estimated numbers of users of the particular drug • Incidence Rates • derived from prospective phase II and phase III clinical trials or large single-center retrospective studies

  11. RADAR Case Reports

  12. RADAR Findings cont.

  13. Timing Info on ADRs Dissemination

  14. Strengths/ Weaknesses Data Sources • Clinical Trial Reports • Comprehensive description individual cases • Few of these reports obtainable • MedWatch/ MAUDE • Contains large number of reports • Underreporting, incompleteness • Physician Queries • Complete • Time and Labor Intensive • Info from Pharmaceutical Company • Difficult to obtain

  15. Difficulties Reporting Rates/ Incidence Estimation • Reporting rates: 1-10% of ADRs reported to MedWatch • Incidence rates: use toxicity info from phase I, II and III trials where drug is used “off-label”

  16. Importance Legal System • Instigated 2 of our ADR investigations • Source of safety information • Ex. Plantiff’s expert testimony on cervistatin-associated rhabdomyolysis • Important end-user of comprehensive safety data • State Attorney General’s Office

  17. Refinements to Post-marketing Surveillance • Make MedWatch accessible online • Systems to prospectively identify persons with ADRs that represent drug toxicities • Ex. plasmapheresis centers (TTP cases), oral surgeons (osteonecrosis) or hematologists (agranulocytosis) • Updating programs currently in place • Collaboration NCI and FDA to synthesize information collected at comprehensive cancer centers

  18. Conclusion • RADAR has exemplify the potential benefits of establishing clinically based, post-marketing surveillance collaboratives that focus on serious ADRs. • Efforts of the RADAR project will ultimately improve safety through early detection and treatment of serious ADRs.

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