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

L.S. Simon; C.V. Strand; M. Boers; P.M. Brooks; P.S. Tugwell; C. Bombardier; J.F. Fries; D.A. Henry; L. Goldkind; G. Guyatt; A. Laupacis; L. Lynd; T.T. MacDonald; M. Mamdani; A.L. Moore; KG Saag; A.J. Silman; R. Stevens; A. Tyndall

doi:https://doi.org/10.3899/jrheum.090591

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

L.S. Simon, C.V. Strand, M. Boers, P.M. Brooks, P.S. Tugwell, C. Bombardier, J.F. Fries, D.A. Henry, L. Goldkind, G. Guyatt, A. Laupacis, L. Lynd, T.T. MacDonald, M. Mamdani, A.L. Moore, KG Saag, A.J. Silman, R. Stevens, A. Tyndall

Epidemiology and Data Science (VUmc)

Research output: Contribution to journal › Article › Academic › peer-review

7 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. The Journal of Rheumatology Copyright © 2009. All rights reserved.

Original language	English
Pages (from-to)	2114-2121
Journal	Journal of rheumatology
Volume	36
Issue number	9
DOIs	https://doi.org/10.3899/jrheum.090591
Publication status	Published - 2009

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https://doi.org/10.3899/jrheum.090591

Cite this

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

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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. The Journal of Rheumatology Copyright {\textcopyright} 2009. All rights reserved.",

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Simon, LS, Strand, CV, Boers, M, Brooks, PM, Tugwell, PS, Bombardier, C, Fries, JF, Henry, DA, Goldkind, L, Guyatt, G, Laupacis, A, Lynd, L, MacDonald, TT, Mamdani, M, Moore, AL, Saag, KG, Silman, AJ, Stevens, R & Tyndall, A 2009, 'How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns', Journal of rheumatology, vol. 36, no. 9, pp. 2114-2121. https://doi.org/10.3899/jrheum.090591

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AU - Simon, L.S.

AU - Strand, C.V.

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AU - Brooks, P.M.

AU - Tugwell, P.S.

AU - Bombardier, C.

AU - Fries, J.F.

AU - Henry, D.A.

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AU - Laupacis, A.

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AU - MacDonald, T.T.

AU - Mamdani, M.

AU - Moore, A.L.

AU - Saag, KG

AU - Silman, A.J.

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AU - Tyndall, A.

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