Digital Endpoint Resource Guide: Respiratory

The task of establishing clinical benefit stands out as one of the most formidable and resource-intensive phases in the development of a new therapy. Regulatory bodies and payers increasingly demand patient-centered outcomes that can substantiate meaningful advantages. The introduction of sensor-based digital health technologies (DHTs) presents an unprecedented opportunity to directly and objectively evaluate individuals' daily functioning.

In the realm of clinical development for respiratory diseases, substantial strides have been made in gaining regulatory acceptance of digital endpoints. This is exemplified by the EMA qualification in COPD and the FDA endorsement of accelerometer-qualified physical activity as a primary measure in pivotal trials. Individuals grappling with respiratory diseases often contend with a significant symptom burden, severely limiting their physical functioning, mobility, participation in daily activities, and sleep quality. Traditionally, assessments of these crucial aspects relied on indirect methods such as in-clinic performance evaluations (e.g., the 6-Minute Walk Test), clinician-reported outcomes, patient-reported outcomes, or composite scores.

Wearables and sensor-based DHTs now offer a continuous and remote stream of patient-centered outcomes, alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.