Challenges and Progress in Adverse Event Ascertainment and Reporting in Clinical Trials

MARISSA N.D. LASSERE and KENT R. JOHNSON for the OMERACT Drug Safety Working Group: THASIA G. WOODWORTH, DANIEL E. FURST, JAMES F. FRIES, JOHN R. KIRWAN, PETER S. TUGWELL, RICHARD O. DAY, and PETER M. BROOKS

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. (J Rheumatol 2005;32:2030-2)

Key Indexing Terms:

ADVERSE EVENT REPORTING
PATIENT QUESTIONNAIRES
RANDOMIZED CONTROLLED TRIALS

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From the University of New South Wales, Department of Rheumatology, St. George Hospital, Sydney; Department of Clinical Pharmacology, Mater Hospital, University of Newcastle, Newcastle, Australia; Novartis Pharma, Basel, Switzerland; Geffen School of Medicine at the University of California in Los Angeles, Los Angeles; Stanford University School of Medicine, Palo Alto, CA, USA; Academic Rheumatology Unit, University of Bristol, Bristol, UK; Centre for Global Health, University of Ottawa, Institute of Population Health, Ottawa, Canada; St. Vincent Hospital, University of New South Wales, Sydney; and Faculty of Health Sciences, University of Queensland, Royal Brisbane Hospital, Herston, Australia.

M.N.D. Lassere, MB, BS, Grad Dip Epi, PhD, FRACP, FAFPHM, Associate Professor in Medicine, Conjoint Appointee University of NSW, Department of Rheumatology, St. George Hospital, Sydney; K.R. Johnson, MD, Senior Research Officer, Department of Clinical Pharmacology, Mater Hospital, University of Newcastle; T.G. Woodworth, MD, Executive Director, Global Therapeutic Area Profiling Head, ABGH, Novartis Pharma; D.E. Furst, Carl M. Pearson Professor of Rheumatology, Geffen School of Medicine, UCLA; J.F. Fries, Professor of Medicine, Stanford University School of Medicine; J.R. Kirwan, BSc, MD, Academic Rheumatology Unit, University of Bristol; P.S. Tugwell, Director, Centre for Global Health, University of Ottawa, Institute of Population Health; R.O. Day, Professor of Clinical Pharmacology, St. Vincent Hospital, University of New South Wales; P.M. Brooks, Executive Dean, Faculty of Health Sciences, University of Queensland, Royal Brisbane Hospital.

Address reprint requests to Dr. M.N.D. Lassere, Department of Rheumatology, St. George Hospital, Kogarah, 2217 NSW, Australia. E-mail: lasserem@sesahs.nsw.gov.au

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