作者: Gerald G. Krueger , Steven R. Feldman , Charles Camisa , Madeleine Duvic , James T. Elder
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摘要: The definitions of psoriasis severity and clinically significant improvement in are used to classify treatments, obtain Food Drug Administration approval, determine product labeling reimbursement. Medical Advisory Board the National Psoriasis Foundation has addressed these issues because their importance clinical trials that conducted gain FDA approval indications. Narrow indications, which without a sound rational basis, will—in this era constant oversight by third party payers—affect physicians’ ability manage patients with psoriasis. Body surface area (BSA) is usually define for trials. It not optimal defining there some low BSA involvement who have very severe high mild We conclude quality life (QOL) standard better than measurement identifying second issue what defines Setting an arbitrarily criterion efficacy new treatments will likely limit development useful treatments. To maximize availability it our thesis should be approved when they been shown produce statistically level well-designed (J Am Acad Dermatol 2000;43:281-5.)