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Workshop
Standardizing Assessment and Reporting of Adverse Effects in Rheumatology Clinical Trials II:
the Rheumatology Common Toxicity Criteria v.2.0
THASIA WOODWORTH, DANIEL E. FURST, RIEKE ALTEN, CLIFTON BINGHAM, DAVID YOCUM, VICTOR SLOAN, WAYNE TSUJI, RANDALL STEVENS, JAMES FRIES, JAMES WITTER, KENT JOHNSON, MARISSA LASSERE, and PETER BROOKS
ABSTRACT. 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. Conclusion. 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. (J Rheumatol 2007;34:1401-14) Key Indexing Terms:
DRUG SAFETY From Roche Pharmaceuticals, Welwyn Garden City, UK; University of California Los Angeles, Los Angeles, California; Schlosspark-Klinik, Berlin, Germany; Johns Hopkins University, Baltimore, Maryland; Genentech, South San Francisco, California; Protalex, New Hope, Pennsylvania; Amgen, Seattle, Washington; Roche Pharmaceuticals, Nutley, New Jersey; Stanford University Medical Center, Palo Alto, California; Center for Drug Evaluation Research, Food and Drug Administration, Rockville, Maryland, USA; University of Newcastle, Leichhardt, Australia; St. George Hospital, Kogarah, Australia; and University of Queensland, Brisbane, Australia. T.G. Woodworth, MD, Roche; D.E. Furst, MD, Professor of Rheumatology, University of California, Los Angeles; R. Alten, MD, Chief, Department of Internal Medicine II, Schlosspark-Klinik, Berlin; C.O. Bingham, MD, Assistant Professor of Medicine, Johns Hopkins University; D.E. Yocum, MD, University of Arizona Health Science Center; V.S. Sloan, MD, Senior Vice President and Chief Medical Officer, Protalex; W.H. Tsuji, MD, Early Development Leader, Amgen; J.F. Fries, MD, Professor of Medicine, Stanford University Medical Center; J.P. Witter, MD, PhD, Center for Drug Evaluation Research: Food and Drug Administration; K.R. Johnson, MD, University of Newcastle; M.N. Lassere, MD, PhD, Associate Professor, St. George Hospital; P. Brooks, MD, FRACP, Executive Dean, Health Sciences, University of Queensland. Address reprint requests to Dr. T. Woodworth, Roche Pharmaceuticals, 6 Falcon Way, Welwyn Garden City, AL7 1TW, UK. E-mail: thasia.woodworth@roche.com |
