Recently, several sensor-based endpoints have been accepted into the FDA’s Clinical Outcome Assessment Qualification program and Europe’s EMA has qualified new activity-based measures as well. However, the industry has been slow to adopt sensors, wearables, and other digital health technologies that offer more frequent and in some cases more accurate measurements. Knowledge gaps may include

• Implementation and data management standards
• The relationship between endpoint properties and the specific DHT device
• Measuring meaningful endpoints

Read on to get the details.