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

doi:10.3899/jrheum.090591

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

Research output: Contribution to journal › Article › 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. (J Rheumatol 2009; 36:2114-21; doi:10.3899/jrheum.090591)

Original language	English
Pages (from-to)	2114-2121
Number of pages	8
Journal	Scandinavian Journal of Rheumatology
Volume	36
Issue number	9
DOIs	https://doi.org/10.3899/jrheum.090591
Publication status	Published - Sept 2009

Keywords

CLINICAL TRIALS
RISK ASSESSMENT
DRUG TOXICITY
PHARMACOEPIDEMIOLOGY

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10.3899/jrheum.090591

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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

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title = "How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns",

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)",

keywords = "CLINICAL TRIALS, RISK ASSESSMENT, DRUG TOXICITY, PHARMACOEPIDEMIOLOGY",

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

year = "2009",

month = sep,

doi = "10.3899/jrheum.090591",

language = "English",

volume = "36",

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journal = "Scandinavian Journal of Rheumatology",

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Simon, LS, Strand, CV, Boers, M, Brooks, PM, Tugwell, PS, Bombardier, C, Fries, JF, Henry, D, Goldkind, L, Guyatt, G, Laupacis, A, Lynd, L, MacDonald, T, Mamdani, M, Moore, A, Saag, KS, Silman, AJ, Stevens, R & Tyndall, A 2009, 'How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns', Scandinavian Journal of Rheumatology, vol. 36, no. 9, pp. 2114-2121. https://doi.org/10.3899/jrheum.090591

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AU - Brooks, Peter M.

AU - Tugwell, Peter S.

AU - Bombardier, Claire

AU - Fries, James F.

AU - Henry, David

AU - Goldkind, Larry

AU - Guyatt, Gordon

AU - Laupacis, Andreas

AU - Lynd, Larry

AU - MacDonald, Tom

AU - Mamdani, Muhammad

AU - Moore, Andrew

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KW - RISK ASSESSMENT

KW - DRUG TOXICITY

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

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Keywords

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