How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns

Lee S. Simon, C. Vibeke Strand, Maarten Boers, Peter M. Brooks, Peter S. Tugwell, Claire Bombardier, James F. Fries, David Henry, Larry Goldkind, Gordon Guyatt, Andreas Laupacis, Larry Lynd, Tom MacDonald, Muhammad Mamdani, Andrew Moore, Ken S. Saag, Alan J. Silman, Randall Stevens, Alan Tyndall

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    4 Citations (Scopus)

    Abstract

    There is great concern about clearly defining benefit and risk in the context of both drug development and clinical practice. in view of this pressure, the OMERACT Executive identified the need to bring together clinical trialists, pharmacoepidemiologists, clinicians, clinical epidemiologists, statistical experts, and regulatory representatives to discuss different approaches to define risk and perhaps improved ways to express it. Each attendee spoke on a given topic and the group was charged to consider the issue of risk in the context of formally posed questions. This article provides a summary of the presentations and Outlines the discussions that followed. (J Rheumatol 2009; 36:2114-21; doi:10.3899/jrheum.090591)

    Original languageEnglish
    Pages (from-to)2114-2121
    Number of pages8
    JournalScandinavian Journal of Rheumatology
    Volume36
    Issue number9
    DOIs
    Publication statusPublished - Sep 2009

    Keywords

    • CLINICAL TRIALS
    • RISK ASSESSMENT
    • DRUG TOXICITY
    • PHARMACOEPIDEMIOLOGY

    Cite this

    Simon, L. S., Strand, C. V., Boers, M., Brooks, P. M., Tugwell, P. S., Bombardier, C., Fries, J. F., Henry, D., Goldkind, L., Guyatt, G., Laupacis, A., Lynd, L., MacDonald, T., Mamdani, M., Moore, A., Saag, K. S., Silman, A. J., Stevens, R., & Tyndall, A. (2009). How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns. Scandinavian Journal of Rheumatology, 36(9), 2114-2121. https://doi.org/10.3899/jrheum.090591