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Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations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

BETHESDA, Md., Jan. 14, 2014 /PRNewswire/ -- Evidera, a leading provider of evidence-based solutions for the healthcare industry, announced that the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, has released its first draft qualification guidance document for a patient-reported outcome (PRO) measure in drug development: Qualification of Exacerbations of Chronic Pulmonary Disease Tool [EXACT] for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease. This document proposes recognition of the EXACT, an electronically administered patient-reported outcome (PRO) daily diary,  as a qualified measure for evaluating symptoms of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD). 

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The EXACT (EXAcerbations of Chronic Pulmonary Disease Tool) was developed under the EXACT-PRO Initiative, a multi-year, multi-sponsor project initiated and led by Evidera. This project involved experts in pulmonary medicine, instrument development, and drug development regulatory issues  dedicated to the task of developing  a single, standardized instrument for evaluating the effects of treatment on acute exacerbations of COPD. Over 500 patients were involved in various stages of instrument development, including participation in focus groups, interviews, and a daily symptom diary study, to make certain the patient's perspective was represented.  Evidera was the first company to convene a consortium of industry experts and multiple pharmaceutical sponsors
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