Digital outcome measures in pulmonary clinical trials.

Abstract

We highlight recent advances in the development and use of digital outcome measures in clinical trials, focusing on how to select the appropriate technology, use digital data to define trial endpoints, and glean important lessons from current experiences with digital outcome measures in pulmonary medicine. A review of emerging literature demonstrates that the use of digital health technologies, particularly pulse oximeters, remote spirometers, accelerometers, and Electronic Patient-Reported Outcomes, has surged in both pulmonary practice and clinical trials. Lessons learned from their use can help researchers to design the next generation of clinical trials leveraging digital outcomes to improve health. In pulmonary diseases, digital health technologies provide validated, reliable, and usable data on patients in real-world environments. More broadly, digital endpoints have accelerated innovation in clinical trial design, improved clinical trial efficiency, and centered patients. As investigators adopt digital health technologies, it is important to follow a framework informed by both the opportunities and challenges of digitization. Successful use of digital health technologies will transform clinical trials by improving accessibility, efficiency, patient-centricity, and expanding opportunities for personalized medicine.