How to ascertain drug safety in the context of benefit. Controversies and concerns

Simon, Lee S. and Strand, C. Vibeke and Boers, Maarten and Brooks, Peter M. and Tugwell, Peter S. and Bombardier, Claire and Fries, James F. and Henry, David and Goldkind, Larry and Guyatt, Gordon and Laupacis, Andreas and Lynd, Larry and Macdonald, Tom and Mamdani, Muhammad and Moore, Andrew and Saag, Ken S. and Silman, Alan J. and Stevens, Randall and Tyndall, Alan. (2009) How to ascertain drug safety in the context of benefit. Controversies and concerns. The Journal of rheumatology : an international journal, Vol. 36. pp. 2114-2121.

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Official URL: http://edoc.unibas.ch/dok/A6003263

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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.

Faculties and Departments:	03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Ehemalige Einheiten Medizinische Fächer (Klinik) > Rheumatologie FPS (Tyndall) 03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Ehemalige Einheiten Medizinische Fächer (Klinik) > Rheumatologie FPS (Tyndall) 03 Faculty of Medicine > Departement Biomedizin > Former Units at DBM > Rheumatologie FPS (Tyndall)
UniBasel Contributors:	De Vere-Tyndall, Alan
Item Type:	Article, refereed
Article Subtype:	Research Article
ISSN:	0315-162X
Note:	Publication type according to Uni Basel Research Database: Journal article
Related URLs:	Document
Identification Number:	pmid: 19738223
Last Modified:	01 Mar 2013 11:14
Deposited On:	01 Mar 2013 11:13

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