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Digital outcome measures in pulmonary clinical trials
Erica Farrand1, Jeffrey J Swigris2
1Department of Medicine, University of California San Francisco, San Francisco, California.
Digital outcome measures in clinical trials are advancing rapidly. These digital health technologies improve trial efficiency, patient-centricity, and personalized medicine in pulmonary research.
Area of Science:
- Pulmonary Medicine
- Digital Health
- Clinical Trials
Background:
- The integration of digital health technologies (DHTs) into clinical practice and research is rapidly expanding.
- DHTs such as pulse oximeters, remote spirometers, accelerometers, and electronic patient-reported outcomes are increasingly utilized in pulmonary medicine.
Approach:
- This review highlights advances in the development and application of digital outcome measures (DOMs) within clinical trials.
- Focus is placed on selecting appropriate technologies, defining trial endpoints using digital data, and extracting lessons from current pulmonary medicine applications.
Key Points:
- DHTs offer validated, reliable, real-world data for patients with pulmonary diseases.
- Digital endpoints enhance innovation, efficiency, and patient-centeredness in clinical trial design.
- A framework addressing both opportunities and challenges is crucial for successful DHT adoption.
Conclusions:
- The adoption of DHTs is transforming clinical trials by improving accessibility and efficiency.
- Digital health technologies foster patient-centricity and expand personalized medicine opportunities.
- Lessons learned from current applications will guide the next generation of digital outcome measure-driven clinical trials.
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