Remote clinical trial monitoring uptake rises but validation questions swirl

Need to Know:

• Wearables can be a value-added aspect to data collection in clinical trials, to complement electronic Patient Reported Outcomes and electronic Clinical Outcome Assessments.
• Central nervous system and cardiovascular spaces continue to be on top in integrating wearable or sensor devices in clinical trials, but rare diseases and oncology are not far behind.
• FDA guidance on validation for wearables exists but the onus is on makers and sponsors to seek additional regulatory guidance.

The boon of remote monitoring such as sensors and trackers in decentralised clinical trials (DCTs)...