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Results from the First Decade of Research Conducted by the Research on Adverse Drug Events and Reports (RADAR) Project

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Abstract

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suitable for further investigation, RADAR collaborators derived case information from physician queries, published and unpublished clinical trials, case reports, US FDA databases and manufacturer sales figures.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.

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Acknowledgments

June M. McKoy had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The authors have no relevant financial conflicts of interest to report.

Financial disclosure

Supported by a grant from the National Cancer Institute: P 30 CA60533, 5-K01 CA134554-05 (JMM), 5-R01-CA125077-03 (DPW), 3-R01CA125077-03S1 (DPW), and 2-R01CA102713-03A2 (DPW).

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Authors and Affiliations

  1. The Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    June M. McKoy, Beatrice J. Edwards & Dennis P. West

  2. Division of General Internal Medicine and Geriatrics, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    June M. McKoy, Matthew J. Fisher, Beatrice J. Edwards, Dustin B. Liebling & Katrina Marie Tulas

  3. Department of Medicine and Preventive Medicine, Northwestern University Feinberg School of Medicine, 645 N Michigan, Suite 630, Chicago, IL, 60611, USA

    June M. McKoy

  4. Department of Emergency Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    D. Mark Courtney

  5. VA Cooperative Studies Program Clinical Research Pharmacy, Albuquerque, NM, USA

    Dennis W. Raisch

  6. University of New Mexico College of Pharmacy, Albuquerque, NM, USA

    Dennis W. Raisch

  7. Department of Pharmacy, Northwestern Memorial Hospital, Chicago, IL, USA

    Marc H. Scheetz & Steven M. Trifilio

  8. Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Steven M. Belknap, Athena T. Samaras, Beatrice Nardone & Dennis P. West

  9. Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Steven M. Belknap

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  1. June M. McKoy
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Correspondence to June M. McKoy.

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McKoy, J.M., Fisher, M.J., Courtney, D.M. et al. Results from the First Decade of Research Conducted by the Research on Adverse Drug Events and Reports (RADAR) Project. Drug Saf 36, 335–347 (2013). https://doi.org/10.1007/s40264-013-0042-x

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