CHEST Guidelines-Enhanced-Drug-and-Device-Development-by-Targeting-

Enhanced-Drug-and-Device-Development-by-Targeting-

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The article discusses efforts to enhance drug and device development by focusing on the relief of dyspnea, a key symptom for patients with chronic obstructive pulmonary disease (COPD). Despite its importance, no dyspnea measurement tools are currently approved by the FDA for clinical trials in the United States. In response to this issue, Dr. Donald A. Mahler and Dr. Sanjay Sethi, along with representatives from the American College of Chest Physicians (CHEST) and the American Thoracic Society (ATS), engaged with the FDA to advocate for the recognition of dyspnea relief as a critical clinical trial outcome.<br /><br />The FDA meeting highlighted the need for reliable, valid, and responsive patient endpoints in COPD trials. The discussion addressed whether dyspnea instruments should be disease-specific or applicable across various respiratory diseases and examined the potential validation or modification of existing tools like the Evaluating Respiratory Symptoms (E-RS). <br /><br />The FDA recognized the challenges but showed openness to the modification of current instruments if substantiated by extensive clinical trial data. The agency encouraged direct engagement with companies to facilitate developing a regulatory pathway for novel interventions that improve patient symptoms without altering disease progression.<br /><br />Ultimately, the article stresses the necessity for collaborative efforts among stakeholders to develop new therapies targeting dyspnea, emphasizing that industry investment is unlikely without FDA-accepted measurement tools. The authors believe that the E-RS instrument is presently the best available option, qualified by the FDA, to measure respiratory symptoms in stable COPD, though further data is needed to refine its responsiveness and validity.

Keywords

dyspnea

COPD

FDA

clinical trials

drug development

device development

E-RS instrument

respiratory symptoms

American Thoracic Society

patient endpoints