{"id":388,"date":"2014-01-14T21:30:47","date_gmt":"2014-01-14T21:30:47","guid":{"rendered":"http:\/\/www.symphonype.com\/?p=388"},"modified":"2014-01-14T21:30:47","modified_gmt":"2014-01-14T21:30:47","slug":"evidera-announces-release-of-fda-draft-guidance-on-use-of-the-exact-to-measure-symptoms-of-copd-exacerbations","status":"publish","type":"post","link":"https:\/\/stg.com\/news\/evidera-announces-release-of-fda-draft-guidance-on-use-of-the-exact-to-measure-symptoms-of-copd-exacerbations\/","title":{"rendered":"Evidera Announces Release of FDA Draft Guidance on Use of the “EXACT” to Measure Symptoms of COPD Exacerbations"},"content":{"rendered":"
\u00a0Evidera<\/a>, 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:\u00a0Qualification 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<\/a>. This document proposes recognition of the EXACT, an electronically administered patient-reported outcome (PRO) daily diary, \u00a0as a qualified measure for evaluating symptoms of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD).<\/p>\n The EXACT (EXA<\/b>cerbations of\u00a0C<\/b>hronic Pulmonary Disease\u00a0T<\/b>ool) 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\u00a0 dedicated to the task of developing \u00a0a 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. \u00a0Evidera was the first company to convene a consortium of industry experts and multiple pharmaceutical sponsors to develop a PRO instrument for use in medical product development trials. The resulting instrument and a derivative measure, the EXACT-Respiratory Symptoms scale (E-RS), are the first to undergo qualification review by the FDA. These instruments are also under qualification review by the European Medicines Agency (EMA). Evidera maintains copyrights to the EXACT and E-RS in English and all translations (50 to date).<\/p>\n “After years of development and testing, with contributions from a diverse team of scholars, practitioners, industry experts, and patients, the release of this draft guidance represents a major milestone for the EXACT,” said\u00a0Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs for Evidera and Principal Investigator and Director of EXACT-PRO Initiative.\u00a0 “Furthermore, as the first qualification guidance from the FDA addressing a specific PRO measure, it could well constitute a significant advancement for PROs in drug development.”<\/p>\n FDA qualification of drug development tools is designed to expedite the drug development process, in this case, research on the effects of new treatments on exacerbations of COPD. The EXACT draft guidance is the first for a PRO instrument, and follows on the heels of the FDA’s release of the final\u00a0Guidance for Industry and FDA Staff \u2013 Qualification Process for Drug Development Tools<\/a>. The draft qualification guidance document for the EXACT was posted on the\u00a0Federal Register<\/i>\u00a0January 10, with public comments due to the FDA within 90 days.\u00a0 When finalized, the qualification guidance for the EXACT will represent the FDA’s current thinking on the use of this PRO instrument in drug development.<\/p>\n