Mobile Sensors in Clinical Trials: A Framework for Regulatory Acceptance

Originally published in Contemporary Clinical Trials.

Patient function is integral to understanding treatment effects and disease progression, and can be better captured using sensor technology.

Despite being a promising method to capture large quantities of real-world evidence, sensors and wearables have not been used as much by the biopharmaceutical industry as one would think.

This article details the reasons for the slow uptick in usage as well as how to address these concerns.

Readers will also learn that a structure for an evidence dossier suitable for regulatory submission may help support the use of mobile sensor technology.

While mobile sensors are often used to generate diagnostic measurements, this report focuses on the devices generating data to support clinical endpoints and new treatment labels.