Unique Clinical Insights From Digital Physical Activity Measures In Phase 3 Immunology Trials

Dr. Jie Shen, Research Fellow and Director of Digital Science at AbbVie, shares lessons learned from incorporating digital measures of physical activity into Phase 3 immunology clinical trials, including considerations for study design, selecting fit-for-purpose DHT, and successful deployment for high data quality and completeness. In these trials, wearable digital health technologies were deployed in two large Phase 3 trials with compliance rates >83%, and digital physical activity measures correlated with self-reported disease severity measures. In one of the trials, digital physical activity measures of step count showed a treatment effect multiple weeks earlier than questionnaire-based measures.

Many patients with autoimmune diseases report challenges with mobility and completing everyday tasks. Using DHTs to profile physical activity in these patient populations is feasible and can provide unique clinical insights for the development of new treatments.