A standardized core set for systemic sclerosis clinical trials. First step in development of combined response index.
SSc can be associated with a high morbidity and mortality. Due to the complexity and heterogeneity of the disease, a composite response measure that will capture differing organ involvements and patient-reported outcomes is desirable. Recently, with participation of the Scleroderma Clinical Trial Consortium, a standardized core set of items were proposed for SSc clinical trials using a structured Delphi exercise. The Delphi exercise identified 11 domains relevant to SSc clinical trials. Currently, efforts are under way to develop a combined response index for clinical trials in diffuse cutaneous SSc.
Khanna
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Department of Medicine, Division of Rheumatology, David Geffen School of Medicine, Los Angeles, CA 90095, USA. dkhanna@mednet.ucla.edu
D002986:Clinical Trials as Topic; D006305:Health Status Indicators; D006801:Humans; D012015:Reference Standards; D012107:Research Design; D012595:Scleroderma, Systemic / Q000188:drug therapy*; D016896:Treatment Outcome
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