In the evaluation of therapies, the physician-based clinical model (eg, global assessment by a physician, change in affected body surface area, index scores, disease-free interval, and survival and recurrence rates) alone is no longer sufficient. In addition to traditional methods of evaluating disease, regulatory agencies now require the assessment of the patient-reported outcomes (PROs).1 These outcomes are pivotal in dermatology because most dermatological diseases are chronic, intermittent, nonfatal, and very visible; cause no permanent physical damage; and their disease activity cannot be measured using serological markers. Initially, PROs focused on inflammatory dermatoses, but they now also include noninflammatory diseases and (benign and malignant) neoplasms, which are associated with different and specific issues (to some extent).
The 3 key players and corresponding outcomes in the evaluation of a treatment.
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