FDA Releases Draft Guidance On Use Of The “E-RS:COPD” To Measure Respiratory Symptoms In Stable COPD
Evidera, a leading provider of evidence‐based solutions for the healthcare industry, is pleased to announce that the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), released its second draft qualification guidance document for a patient-reported outcome (PRO) measure: Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use.
The Evaluating Respiratory Symptoms of COPD (E-RS™:COPD) was developed by Evidera as part of the EXACT-PRO Initiative, a multi-year, multi-sponsor project initiated and led by Evidera. The E-RS is a derivative of the EXACT®, the first PRO measure qualified by the FDA (January of 2014), and used to assess acute exacerbations of COPD. The E-RS:COPD was designed to measure respiratory symptoms in patients with stable COPD and test the effects of treatment on this outcome. The instrument has been and is being used in multiple clinical trials and academic studies. Evidera maintains copyrights to the EXACT and E-RS and facilitates its use in clinical research.
“Respiratory symptoms can be disabling to patients with COPD, and symptomatic relief is an important goal of treatment. The E-RS:COPD will help us improve our understanding of the effects of treatment on these important symptoms,” said Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs for Evidera and Principal Investigator and Director of the EXACT-PRO Initiative. “We’re pleased the FDA has recognized both the EXACT and E-RS as outcome measures for use in drug development trials of COPD through the qualification process.”
More than 12 million people in the U.S. have been diagnosed with COPD, and an additional 12 million in the U.S. are thought to have undiagnosed COPD according to the National Institutes of Health. COPD is the third leading cause of death in the U.S. according to the Centers for Disease Control and Prevention. There is no cure, but every effort is being made to understand, treat, and manage the effects of this disabling disease. To learn more about the E-RS and EXACT, visit www.exactproinitiative.com.