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Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations
Date:1/14/2014

ssness, coughing, mucus, and other symptoms.  (For more information, visit http://www.nhlbi.nih.gov/health/health-topics/topics/copd/.)  COPD affects over 24 million people in the US and over 64 million people worldwide.  Exacerbations are an acute worsening of the disease that can lead to substantial morbidity, including lost work days, clinic or emergency room visits, and hospitalizations, and may cause death.   Understanding these events and developing new treatments to reduce their frequency, severity, and duration, are important to patients and priorities for medical research.   The EXACT was designed to advance the science through precise, standardized assessment of exacerbations to facilitate basic and applied research on exacerbations, including onset, acuity, recovery, relapse, and the effects of preventive and acute treatment.  The EXACT is being used in multiple investigations, including pharmaceutical trials and natural history studies of COPD.  

"EXACT qualification marks a major milestone in the partnership between FDA and developers of patient-focused clinical outcome assessments (COAs) targeted for clinical trial use," said Laurie Burke, former Director of CDER's Study Endpoints and Labeling Development Staff that leads the COA qualification process at FDA.  "The EXACT development process enabled FDA to pave the way for more PRO measures to be qualified for drug development.  Moreover, COPD patients in clinical trials now have a clear voice in the measurement of treatment benefit and the development of new treatments based on their symptom experience."

About Evidera
Evidera, a wholly owned subsidiary of Symphony Technology Group, provides health economics, outcomes research, market access, data analytics and epidemiology services. We partner with life sciences organization
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