How Wearable Technologies are Creating New Clinical Trial Endpoints

Wearable technologies are gaining a lot of interest as a means of data collection in biopharmaceutical and healthcare research and development. These technologies help people monitor their health in new, convenient ways. Further, they aid healthcare professionals to better diagnose and care for their patients. 

As a prominent example, scientists from Yale University and the Mayo Clinic recently examined the design of clinical trials in heart failure using an Apple Watch app. Working with digital therapeutics firm Biofourmis, they assessed the significance of functional capacity and quality of life measures in the trials. Interestingly, patient-centric endpoints based on symptoms or physical function were found to be more rapidly identifiable than traditional endpoints based on the hospitalization risk or survival outcomes. The study leveraged the BiovitalsHF app-based mobile platform, which could help regulators use these patient-centric endpoints while approving heart failure drugs. Eventually, this could potentially hasten the drug approval process.

Other Examples of Innovative Wearables in Healthcare

Samsung has developed a series of wearable exoskeletons known as the Gait Enhancing and Motivating System (GEMS). These exoskeletons help people with mobility issues or knee, ankle, and hip injuries, or simply people who want to be more active. The GEMS makes it easier to walk by correcting posture, saving energy, and increasing pace. With the help of AR glasses, users can climb mountains, work out virtually, or even walk underwater. The GEMS collects and analyzes the results from these activity sessions and provides personalized action recommendations. 

Another breakthrough wearable technology is the Butterfly iQ personal, whole-body ultrasound imager that can be connected to an iPhone. Healthcare professionals can fit this imager into their pockets and easily use it to perform challenging ultrasound scans.

The Omron HeartGuide is a wearable blood pressure monitor that features miniaturized components and an inflatable cuff within the watch band to facilitate blood pressure readings. By pairing the monitor with the HeartAdvisor app, users can track blood pressure and sleep quality. These personalized data help better understand how lifestyle impacts heart health and provides actionable insights for the user.

Future of Wearable Technologies in Clinical Research

Wearable technologies have the potential to transform healthcare and drug development by changing the collection, processing, and visualization of data. The potential applications of wearable technologies are diverse and extend to multiple therapeutic areas. However, more data are needed from clinical trials to better understand and adopt these technologies at the clinical level. Further dialogue and discussions between device manufacturers and the biopharmaceutical industry will help develop a shared understanding of the technologies and fulfill the requirements of clinical validation. 

Want to learn more? Check out our recent Fireside Chats with leading experts in wearables, virtual trials, and other digital health technologies!


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