The U.S. Food and Drug Administration (FDA) 2006 draft guidance on "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" has engendered wide discussion about patient-reported outcome (PRO) domains that should be endpoints in clinical trials. Reducing the severity and impact of symptoms is a natural intervention endpoint for cancer, a condition associated with considerable symptom burden. Because symptoms are best described by patients who have them, including PROs as measures of treatment effectiveness or the differences among treatments provides essential information about the efficacy and toxicity of a treatment and its effects on function. The FDA guidance provides a framework for addressing such issues as clinical significance, study design, and statistical methods as they relate to applications for labeling claims; however, no set of recommended approaches for assessing specific symptoms by patient report in clinical trials exists, other than for pain. Accordingly, an interdisciplinary workgroup, Assessing the Symptoms of Cancer using Patient-Reported Outcomes (ASCPRO), has been formed to generate evidence-based recommendations for the assessment of patient-reported cancer-related symptoms and the use of that information to facilitate clinical research and decision making. ASCPRO is among the first working groups to focus primarily on nonpain symptoms, including fatigue, sleep disturbance, appetite loss, depression, cognitive impairment, and shortness of breath. ASCPRO members are stakeholders in optimal symptom assessment, including patient advocates, academics, clinicians, those who pay for symptom control and monitor quality of care, and those who produce products that palliate cancer-related symptoms but that may also engender treatment-related symptoms. © 2010 U.S. Cancer Pain Relief Committee.
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