Research ArticleOMERACT 9: International Consensus Conference on Outcome Measures in Rheumatology, Kananaskis Village, Alberta, Canada, May 27–31, 2008
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 and ALAN TYNDALL
The Journal of Rheumatology September 2009, 36 (9) 2114-2121; DOI: https://doi.org/10.3899/jrheum.090591
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
REFERENCES
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- Simon LS,
- Strand CV,
- Boers M,
- et al.,
- 2.↵
- Higgins PT,
- Green S
- 3.↵
- 4.↵
- Atkins D,
- Best D,
- Briss P,
- et al.,
- the GRADE Working Group
In this issue
The Journal of Rheumatology
Vol. 36, Issue 9
1 Sep 2009
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
The Journal of Rheumatology Sep 2009, 36 (9) 2114-2121; 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
The Journal of Rheumatology Sep 2009, 36 (9) 2114-2121; DOI: 10.3899/jrheum.090591
Jump to section
- Article
- Abstract
- 1. ASSIGNING CAUSALITY (Larry Goldkind)
- 2. UTILITY OF LARGE STREAMLINED TRIALS TO DEFINE RISK (Andreas Laupacis, Tom MacDonald)
- 3. UTILITY OF METAANALYSIS OF RCT IN EVALUATING ADVERSE EFFECTS OF DRUGS (Andrew Moore, David Henry)
- 4. POSTMARKETING SURVEILLANCE (Jim Fries)
- 5. WHAT ARE THE UTILITIES OF DRUG REGISTRIES TO DEFINE RISK? (Claire Bombardier, Alan Silman)
- 6. PHARMACOEPIDEMIOLOGIC STUDIES (Muhammad Mamdani, Ken Saag)
- 7. SIMPLE VERSUS COMPLEX METRIC (Maarten Boers)
- 8. COMPLEX FRAMEWORKS (Larry Lynd)
- 9. GRADING OF RECOMMENDATIONS ASSESSMENT, DEVELOPMENT, AND EVALUATION (GRADE) WORKING GROUP (Gordon Guyatt)
- 10. OTHER MODELS OF RISK: NONTREATMENT (Randall Stevens)
- 11. OTHER MODELS OF RISK: SAFETY OF CELLULAR THERAPEUTICS (Alan Tyndall)
- 12. CONDITIONAL APPROVALS (Andreas Lapaucis)
- CONCLUSIONS/FUTURE RESEARCH
- Footnotes
- REFERENCES
- Figures & Data
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- References
- eLetters