Challenges and progress in adverse event ascertainment and reporting in clinical trials

Lassere, Marissa N. D., Johnson, Kent R., Woodworth, Thasia G., Furst, Daniel E., Fries, James F., Kirwan, John R., Tugwell, Peter S., Day, Richard O. and Brooks, Peter M. (2005) Challenges and progress in adverse event ascertainment and reporting in clinical trials. Journal of Rheumatology, 32 10: 2030-2032.

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Name Description MIMEType Size Downloads
Author Lassere, Marissa N. D.
Johnson, Kent R.
Woodworth, Thasia G.
Furst, Daniel E.
Fries, James F.
Kirwan, John R.
Tugwell, Peter S.
Day, Richard O.
Brooks, Peter M.
Title Challenges and progress in adverse event ascertainment and reporting in clinical trials
Journal name Journal of Rheumatology   Check publisher's open access policy
ISSN 0315-162X
Publication date 2005-10-01
Sub-type Article (original research)
Volume 32
Issue 10
Start page 2030
End page 2032
Total pages 3
Editor Duncan A. Gordon
Yvonne Pigott
Place of publication Toronto, ON, Canada
Publisher Journal of Rheumatology Publishing
Collection year 2005
Language eng
Subject C1
Formatted abstract
Toxicity, safety, and tolerability are integral facets of patient risk/benefit decisions, yet the capacity to define, measure, and compare these aspects is underdeveloped compared to aspects of efficacy. There are many reasons for this, scientific and administrative, but all are surmountable. Probably the greatest primary obstacle is the absence of a measurement instrument designed specifically for this purpose. There are increasing calls from various stakeholders for better evidence, and therefore better ascertainment, in this area, especially in randomized trials, and for these reasons OMERACT began deliberations about these concepts in 1994. A prototype coding instrument (the Rheumatology Common Toxicity Criteria) was developed and discussed at OMERACT 5. In the 2 years before OMERACT 7, a process of concept development and iterative design and testing were conducted to develop a patient self-report and investigator-reported adverse event instruments designed for use in trials at the time of visit. The predominant workload is performed by the patient in a self-report checklist, which is then mapped by the trialist onto a medically sophisticated version. This article presents background on the process of developing a dual adverse event instrument, which was presented and critically discussed in detail at OMERACT 7.
Keyword Rheumatology
Adverse Event Reporting
Patient Questionnaires
Randomized Controlled Trials
Toxicity Index
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

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Created: Wed, 15 Aug 2007, 07:29:17 EST