%0 Journal Article %1 Simon2009 %A Simon, Lee S %A Strand, C Vibeke %A Boers, Maarten %A Brooks, Peter M %A Tugwell, Peter S %A Bombardier, Claire %A Fries, James F %A Henry, David %A Goldkind, Larry %A Guyatt, Gordon %A Laupacis, Andreas %A Lynd, Larry %A Macdonald, Tom %A Mamdani, Muhammad %A Moore, Andrew %A Saag, Kenneth G %A Saag, Ken S %A Silman, Alan J %A Stevens, Randall %A Tyndall, Alan %D 2009 %J The Journal of rheumatology %K AntirheumaticAgents AntirheumaticAgents:adverseeffects AntirheumaticAgents:therapeuticuse BiomedicalResearch Drug-RelatedSideEffectsandAdverseReactions Humans Pharmacoepidemiology Postmarketing ProductSurveillance Registries RheumaticDiseases RheumaticDiseases:drugtherapy RiskAssessment RCT %N 9 %P 2114-21 %R 10.3899/jrheum.090591 %T How to ascertain drug safety in the context of benefit. Controversies and concerns. %U http://www.ncbi.nlm.nih.gov/pubmed/19738223 %V 36 %X 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. %@ 0315-162X

@article{Simon2009, 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.}, added-at = {2023-02-03T11:44:35.000+0100}, author = {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, Kenneth G and Saag, Ken S and Silman, Alan J and Stevens, Randall and Tyndall, Alan}, biburl = {https://www.bibsonomy.org/bibtex/278386afb187e3f9a2d3fd31b57409757/jepcastel}, city = {Harvard Medical School, Boston, MA, USA. omeract@uottawa.ca}, doi = {10.3899/jrheum.090591}, interhash = {2555a496b3d10ef72f3a5cac098e28f2}, intrahash = {78386afb187e3f9a2d3fd31b57409757}, isbn = {0315-162X}, issn = {0315-162X}, journal = {The Journal of rheumatology}, keywords = {AntirheumaticAgents AntirheumaticAgents:adverseeffects AntirheumaticAgents:therapeuticuse BiomedicalResearch Drug-RelatedSideEffectsandAdverseReactions Humans Pharmacoepidemiology Postmarketing ProductSurveillance Registries RheumaticDiseases RheumaticDiseases:drugtherapy RiskAssessment RCT}, month = {9}, note = {5429<m:linebreak></m:linebreak>JID: 7501984; 0 (Antirheumatic Agents); ppublish;}, number = 9, pages = {2114-21}, pmid = {19738223}, timestamp = {2023-05-04T08:59:38.000+0200}, title = {How to ascertain drug safety in the context of benefit. Controversies and concerns.}, url = {http://www.ncbi.nlm.nih.gov/pubmed/19738223}, volume = 36, year = 2009 }