Assessing the Symptoms of Cancer Using Patient-Reported Outcomes (ASCPRO): Searching for Standards

The U.S. Food and Drug Administration (FDA) 2006 draft guidance on "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" has engendered wide discussion about patient-reported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...