Could this wearable be the future of clinical trials?

A new wearable could mark the future for clinical trials through the better use of real-world evidence to support the approval of new therapies.

Healthtech company Shimmer’s wearable sensor Verisense includes a wrist-based Inertial Measurement Unit (IMU) that can capture biometric data, such as activity and sleep. In addition, seven sensors can be placed on different parts of a participant’s body to study complex musculoskeletal or neurological conditions. 

The platform is designed to place the minimum burden on participants. A base station provided with the platform is placed in a location the user visits every day and is used to capture data. More so, a six-month battery life ensures users aren’t constantly charging the wearable, which can even be worn in the shower or bath.

Clinical trial sponsors are given access to raw participant data, which can then be transferred to an electronic data capture system to ensure data integrity. In addition, algorithms provide validated metrics and a monitoring dashboard shows the status of all clinical sites.

The launch comes shortly after the FDA announced a new framework to support the use of real-world data in approving drugs and biologics. In recent years, digital health products such as wearables have largely focused on consumer needs, blending health tools and alerts into user-friendly smartwatches. Now with major tech companies such as Apple developing more healthtech services, it makes sense that a company like Shimmer would aim to transform the clinical world.

More so, the rise in wearable technology means that there is now a potential to garner patient data that is produced outside of the clinical space and which can measure a patient’s quality of life far more accurately.

And while wearable technology has massively progressed in recent years, offering features including fall detection and electrocardiograms, Shimmer states that current devices can’t offer the specific requirements of a clinical trial. 

“An effective clinical trial solution has to meet very specific requirements, such as providing access to raw participant data and purpose-built management tools, while placing the minimum burden on sponsors, sites and participants,” Geoff Gill, president of Shimmer Americas said. “This can’t be done by simply repurposing consumer wearable devices or other current devices. We started by systematically understanding the needs of sponsors, sites, and participants, then designed Verisense from the ground up to meet those needs. The initial feedback from customers has been overwhelmingly positive. Starting in March, customers are planning to use Verisense in trials for Alzheimer’s disease, Parkinson’s disease, cancer-related fatigue, and stroke.”

The use of Verisense in clinical trials will be particularly important for chronic conditions like diabetes, which require access to real-world participant data.

“There is a growing demand from pharmaceutical companies, regulators and payers to factor real-world data (RWD) into healthcare decision making. They want to ensure that new therapies, especially those for chronic conditions, deliver objective improvements to participants’ health and quality of life,’ Gill added.