Evidera, a biotechnology company that provides solutions based on current evidence for the healthcare industry, recently announced the release of a draft qualification opinion of the European Medicines Agency’s (EMA) regarding two assessment measures to examined treatment outcomes in clinical trials of COPD. The measures are the E-RS (EXACT-Respiratory Symptoms) and the EXACT (Exacerbations of Chronic Pulmonary Tool), two patient-reported outcome (PRO) tools.
Evidera initiated and led a multi-year, multi-sponsor project called EXACT-PRO Initiative, a daily symptom diary that forms the basis for these two assessment measures. The opinion of the European Medicines Agency, which has been available to the public since April 13th, reports current evidence that validates the use of the two tools as exploratory COPD drug trials endpoints. Regarding EXACT, the EMA’s opinion notes: “the suggested attempt to characterize COPD exacerbation events in terms of severity, duration and frequency in a highly-standardised and more symptom-driven manner can be considered a valuable contribution to the search for suitable efficacy endpoints in COPD trials.” EMA is accepting comments until 25 May 2015.
While the E-RS is under review by the FDA, the FDA released their EXACT draft qualification in 2014, which clarifies EXACT as a “well-defined and reliable measure of symptoms of ABECB-COPD for use in phase 2 studies.”
“The release of qualification statements from the EMA and FDA are important milestones in patient-centered outcomes research,” said Nancy Kline Leidy, Ph.D., Principal Investigator of the EXACT-PRO Initiative and Senior Vice President, Evidera in a recent press release. “PRO measures not only represent the patient’s voice, but are instrumental to scientific progress. The EXACT and E-RS are being used in clinical studies to further our understanding of COPD and the efficacy of interventions to alleviate exacerbations and provide symptomatic relief for people with this condition.”
The standardized PRO assessment tool was developed by a consortium convened by EXACT-PRO. The diary has been translated into 55 different languages and has been used in more than 65 clinical trials, including 24 trials evaluating new treatments for COPD.