FDA clears PRO for exploratory use in COPD

FDA will allow use of a new patient-reported outcome instrument in clinical trials to support approval and labeling claims for compounds to treat chronic obstructive pulmonary disease. The tool, Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD), measures the severity of respiratory symptoms in COPD patients.

Draft guidance FDA released Tuesday said E-RS: COPD is "qualified" as an exploratory endpoint for clinical studies, but said "additional development work is needed to further assess measurement properties." ...