Shimmer, a Dublin-based wearable sensor company, has launched a new sensor platform for clinical trials called VeriSense. At launch, the platform will work with Shimmer's IMU, or inertial measurement unit, sensor, which can measure activity and sleep from the wrist, as well as network with sensors elsewhere on the body to monitor musculoskeletal and neurological conditions.
The company has been making robust wearable sensors for the research world since 2006. But VeriSense is their first data platform aimed at filling the unique needs associated with clinical trials
"There is a growing demand from pharmaceutical companies, regulators and payers to factor real-world data into healthcare decision making," Geoff Gill, president of Shimmer Americas, said in a statement. "They want to ensure that new therapies, especially those for chronic conditions, deliver objective improvements to participants' health and quality of life. That requires access to real-world participant data and has spurred the rapid growth in wearable technologies to measure objective quality of life indicators, such as activity levels and sleep patterns."
What's the impact
In order to be as useful as possible in clinical trials, the Verisense platform is designed to give trial sponsors access to raw clinical data — as opposed to the processed data they might receive from consumer devices like a Fitbit. But the system also uses algorithms to turn that raw data into validated metrics. The data is stored securely and sponsors can access it in the form of a dashboard, which can also be configured to give alerts when data moves out of a certain range.
"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," Gill 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 wearable sensors are also easy to use for participants. They have a six-month battery life and can be worn in the bath or shower, and data transfer happens wirelessly and automatically.
What's the trend
Clinical trials have been employing wearables for years, but they aren't without their problems — and over the last three years, those problems have been under the microsope. For instance, last fall, the Duke-Margolis Center for Health Policy put out a report on using mobile devices to collect real-world clinical trial data.
At BIO last year, a number of pharma companies took the stage to talk about the issues that plague consumer devices.
“We’re trying to take the real world and encode it in a way that makes sense," Dr. Daniel Karlin, Pfizer’s head of clinical, informatics, regulatory strategy, digital medicine, and the Pfizer Innovation Research Lab, said at the time. "And we’ve hit a point in that effort where there’s a recognition … that without some efforts at standardization, and interoperability, and research that’s reproducible from one site to another and one device to another, it’s going to be really, really difficult to have the observations made by digital devices take on real meaning."
Arguably, the FDA, which has been beating the drum on real-world evidence since 2016, is most responsible for prompting the industry's focus on solving the data problems presented by today's wearables. Real-world evidence and post-market surveillance are also aspects of the agency's Pre-Cert program.