Establishing clinical benefit is one of the most challenging and costly steps in developing a new therapy. Regulatory agencies and payers are increasingly demanding patient-centered outcomes that can demonstrate meaningful benefits. With the advent of sensor-based digital health technologies (DHTs), we now have an unprecedented opportunity to directly and objectively assess how people feel and function in their lives.
In rheumatology, both FDA and EMA have highlighted the need to assess physical function and walking as key efficacy endpoints.1,2 People living with arthritis, myositis and similar conditions are suffering from pain, weakness and stiffness on a daily basis that severely limit their physical functioning and mobility,3,4 and lead to poor sleep quality. Traditionally, these concepts of interest can only be assessed indirectly by in-clinic performance assessment (i.e., 6-Minute Walk Test), clinician-reported outcomes (i.e., Myositis Damage Index), patient-reported outcomes (i.e, Patient Activity Scale), or composite scores (American College of Rheumatology20 [ACR20]). Wearables and sensor-based DHTs provide these patient-centered outcomes continuously and remotely, reducing the burden of trial participation, increasing the probability of trial success and improving management of the conditions.5