Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v.2.0.
OBJECTIVE
The OMERACT Drug Safety Working Group focuses on standardization of assessment and reporting of adverse events in clinical trials and longitudinal and observational studies in rheumatology. This group developed the Rheumatology Common Toxicity Criteria (RCTC) in 1999, building on the Oncology Common Toxicity Criteria. At OMERACT 8, a workshop group reviewed the use of the RCTC and other instruments in rheumatology clinical trials to date, to revise and to stimulate its implementation.


METHODS
The Working Group drafted a revision of the RCTC after an iterative examination of its contents, terms, and definitions. The RCTC were compared with the Oncology Common Toxicity Criteria (CTC v.2.0), and the Common Terminology Criteria for Adverse Events (CTCAE v.3.0). In addition a pharmaceutical company focus group met to clarify the challenges of application of RCTC terms and definitions, relative to the standard in pharmaceutical clinical trials, i.e., verbatim recording of adverse events followed by mapping to Medical Dictionary of Drug Regulatory Activities (MedDRA) terms. The workshop focused on the proposed revision of RCTC to version 2.0 and on the research agenda, including a validation of the RCTC in future trials.


RESULTS
At OMERACT 8, breakout groups amended the contents of the 4 current and 2 new categories of adverse event terms within the draft RCTC v.2.0. Participants recognized the need to standardize the definitions for disease flares, infection, malignancy, and certain syndromes such as drug hypersensitivity and infusion reactions. Moderate consensus (62%) was reached in the final plenary session that the amended RCTC v.2.0 should be promulgated and tested in available trials of anti-tumor necrosis factor agents.


CONCLUSIONS
The RCTC has face validity and construct validity. However, documentation of discrimination and feasibility (the other elements of the OMERACT filter) is needed. Collaboration with drug safety working groups in rheumatology professional organizations is necessary to enable this project.
Woodworth
Thasia
T
Roche Pharmaceuticals, Welwyn Garden City, UK. thasia.woodworth@roche.com
Furst
Daniel E
DE
Alten
Rieke
R
Bingham
Clifton O
CO
Bingham
Clifton
C
Yocum
David
D
Sloan
Victor
V
Tsuji
Wayne
W
Stevens
Randall
R
Fries
James
J
Witter
James
J
Johnson
Kent
K
Lassere
Marissa
M
Brooks
Peter
P
D018501:Antirheumatic Agents / Q000009:adverse effects*; D017322:Clinical Trials, Phase II as Topic; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification* / Q000175:diagnosis / Q000517:prevention & control; D017144:Focus Groups; D006801:Humans; D007391:International Cooperation; D008137:Longitudinal Studies; D011785:Quality Assurance, Health Care / Q000379:methods / Q000592:standards*; D015203:Reproducibility of Results; D012216:Rheumatic Diseases / Q000188:drug therapy*
D018501:Antirheumatic Agents