Insights
Research and Clinical Trial Topics
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...
Navigating the FDA Digital Health Technology Guidance: Insights for Respiratory Drug Developers
In December 2023, the FDA published its final release of "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” a pivotal step in formalizing regulatory standards and guidance for remote data collection in clinical trials. As the FDA...
Cough and Wheeze Endpoint Measurement: Objective or Subjective?
Changes in symptoms such as coughing and/or wheezing are highly important endpoints in clinical trials focused on COPD, Asthma, IPF, Cystic Fibrosis, and other indications. With the growing availability of digital health technologies (DHTs) and wearables, it is now...
Takeaways from JP Morgan Week 2023
I returned from the exciting JP Morgan 41st Annual Healthcare Conference last week in San Francisco and greatly enjoyed learning from the speakers and leaders in the pharmaceutical industry on the latest trends and thinking. I put together this short blog that...
Healthcare and Remote Patient Monitoring Topics
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