Establishing clinical benefit is touted as one of the most formidable and expensive stages in developing a new therapy and is increasingly demanded by regulatory agencies and payers. However, with the help of sensor-based digital health technologies (DHTs), the industry has an unparalleled opportunity to directly and objectively evaluate individuals' daily functioning and demonstrate the substantial advantages of patient-centered outcomes.
For heart failure conditions, the burden remains significant, with its physical symptoms causing severe debilitation. People with heart failure prioritize symptom stabilization or improvements in physical functioning, dyspnea, and fatigue over traditional outcomes like hospitalization and mortality. In the past, assessing these crucial aspects could only be done indirectly through in-clinic performance assessments (such as the 6-Minute Walk Test), clinician-reported outcomes (e.g., The New York Heart Association Functional Classification [NYHA Functional Classification]), or patient-reported outcomes (e.g., Chronic Heart Failure Questionnaire).
Both the FDA and the EMA have taken notice of this paradigm shift and, in their guidance documents, stress the importance of incorporating physical function as a key efficacy endpoint. Moreover, the FDA suggests that accelerometer data can be utilized as a novel endpoint. This is where wearables and sensor-based DHTs come into play, providing continuous and remote patient-centric outcomes. By doing so, they alleviate the burden of trial participation, increase the likelihood of trial success, and enhance the management of these conditions.
Learn how actigraphy can objectively measure treatment effects on a variable that drives patient outcomes. By applying these tools, sponsors can prepare trials to better align with the FDA’s position on patient-centric drug development.