Wearable sensor maker MC10 is teaming up with biopharma company AbbVie on a new set of multiple sclerosis (MS) clinical trials. The pair plan to use MC10’s FDA cleared wearable sensor technology, dubbed the BioStamp nPoint system, to help keep track of a patient’s physiological data and outcomes during the trials.
The flexible and stretchable electronic sensors landed FDA clearance last year to record vital signs like movement and heart rate and display them on an Android phone provided by MC10. The technology is also able to monitor derived data such as heart rate variation, posture classification and several sleep-related metrics.
WHY IT MATTERS
The pharma industry has been interested in how wearable technologies and other digital health products can help clinical research and development. The technologies have the potential to alleviate a patient’s responsibility to report their outcomes, and can also provide additional data.
“Patients now don’t have to report as much,” Matteo Lai, cofounder and CEO of Empatica, said during a MassBio panel last week. “The data is collected passively and there are not as many actions that they have to do.”
WHAT'S THE TREND
However, there are challenges associated with using wearables in a clinical setting. Unlike consumer wearables the pharma industry needs clinical grade technology.
Many pharma companies are now looking into research specific wearables. In fact, MC10 has previously teamed up with UCB for Parkinson’s Disease data research.
MC10 is far from the only company working with big pharma to employ wearable data in clinical trials.
Another player in this field is Alphabet subsidiary Verily, which landed FDA clearance for its Verily Study Watch and its on-demand ECG feature. The watch is a prescription-only device, and was designed to record, store, transfer and display single-channel ECG rhythms.
“There are many wearables and other gadgets that claim to be wearables for clinical trials, but there is a big difference between something that you truly use for clinical trials, to get clinical validation and real-world evidence, and other wearables that are there for consumer use,” Luba Greenwood, who focuses on strategic business development and corporate ventures at Alphabet subsidiary Verily, said during the MassBio panel.
Last week Verily announced a series of new strategic partnerships with four global pharmaceutical companies that will bring low-burden digital data collection and analysis tools to clinical research projects.
ON THE RECORD
“We are excited to explore the BioStamp nPoint System’s ability to unobtrusively collect clinically relevant data continuously from subjects in more natural settings. This technology has the potential to improve the quality of data we collect and at the same time reduce the burden on study participants,” Dr. Michael Gold, VP of development neurosciences at AbbVie, said in a statement.