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Research and Clinical Trial Topics
Regulatory Pathways for Cough Monitoring in Clinical Trials: FDA Validation Requirements Explained
Cough monitoring has emerged as an increasingly common practice in research studies and drug development in recent years to objectively measure changes in subjects' cough. As drug developers consider including cough frequency as an endpoint in their studies,...
Why the Tegaderm™ Adhesive is a Trusted, Patient-Friendly Solution for the RESP® Biosensor
In research studies and healthcare settings, minimizing patient burden is essential for reliable data collection with wearables and devices. At Strados Labs, we understand the importance of these factors with the RESP® Biosensor, which is designed to continuously...
Cough as an Endpoint in IPF Trials: Why it Matters
Increased importance has been placed in recent years on the ability of idiopathic pulmonary fibrosis (IPF) treatments to impact how patients feel and function, beyond survival (Raghu, et al., 2024). In IPF, one of the most burdensome symptoms impacting how patients...
Leicester Cough Questionnaire: An Overview
The Leicester Cough Questionnaire (LCQ)1 is a self-reporting tool developed by S.S. Birring and others to evaluate the impact of chronic cough on a patient's quality of life. Chronic cough,2 which impacts between 10-20% of the US population,3 is a cough that can last...
Unpacking the FDA Advisory Committee Meeting for Merck’s Gefapixant
In November 2023, Merck's chronic cough drug, gefapixant, faced a decisive setback from the FDA Advisory Committee. The concerns highlighted insufficient evidence for the drug providing a clinically meaningful benefit to adults with refractory chronic cough (RCC) or...
Beyond Cough Count: Why It’s Time to Go Deeper in Cough Trials
24-hour cough frequency has traditionally been recognized as the ‘gold standard’ primary endpoint for indications such as refractory chronic cough, chronic bronchitis, and IPF-related cough. While frequency is undoubtedly a valuable metric to measure for cough, there...
Healthcare and Remote Patient Monitoring Topics
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