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ArtikelResponse Criteria for clinical Trials in Systemic Lupus Erythematosus  
Oleh: Liang, MH ; Fortin, PR
Jenis: Article from Journal
Dalam koleksi: Lupus vol. 4 no. 5 (1995), page 336-338.
Topik: Clinical Trials; Response Index
Fulltext: 336.full.pdf (281.93KB)
Isi artikelA clinical pearl from experienced clinicians states that a treatment should never be started unless the criteria of success can be defined beforehand. Similarly, a clinical trial should never start unless the primary endpoints and the expected difference are defined. Lupus is a chronic disease. Progress in its management will be directed towards control of mild to moderately active disease or important subsets of patients such as those with antiphospholipid antibody. Clinical trials in systemic lupus erythematosus have been hampered by small numbers of patients and the heterogeneity of the disease; by the lack of a standardized definition of disease, its severity, measures of disease activity and a definition of a clinically important change.
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