Participants of clinical trials organized by Parexel can now visit trial sites less often. Through a new program, the CRO is offering to collect study subject data remotely using wearables and sensors.
This new service, powered by the CRO’s Perceptive MyTrials analytics platform, is “a complete solution” that allows it to capture, securely transmit, store and monitor data, as well as generate alerts, Xavier Flinois, president of Parexel Informatics, told FierceCRO.
“We are organizing this through partnering the provision of wearable devices, creating efficiencies for sponsors and eliminating the need for them to contract with another party,” he said.
The system is currently equipped with six kinds of wearable devices, including a spirometer, blood pressure meter, pulse oximeter, blood glucose monitor, body weight scale and activity monitor, Flinois said.
OSIsoft, a California-based company focused on sensor-based data management, is one of the technology providers for this new service, and Flinois said those partners have more than 50 devices available to Parexel based on client need.
Using medical devices to remotely collect data could reduce the number of clinical assessments and on-site visits during the trial process. Although it’s difficult to generalize how many visits a participant need to pay a trial site throughout a clinical trial since it varies by indication and study phase, many protocols require more than 10 visits, Flinois said. To his prediction though, that number, especially in some phase 4 studies, can be reduced to only an initial enrollment visit or an annual visit.
And the good news is not just for trial participants—the potential that it could decrease trial costs and provide alternative data also benefits sponsors. The recent passage of the 21st Century Cures Act has already left more possibility for inclusion of real-world or quality-of-life data into the regulatory agency’s consideration of approving a drug. That could give rise to the need to leverage those data sources in and outside clinical trials.
Besides, using wearables would also allow CROs and sponsors to collect data more often. “Frequent collection of this data can provide real-time meaningful insights into a study subject’s behavior and health outside of visits, supporting better compliance and real-time user feedback,” said the company in a press release.
Flinois said that Parexel’s offering would allow sponsors “to more easily demonstrate safety and/or efficacy and differentiate treatments from competition using remote monitoring approaches.”
The notion of remote patient monitoring is not new in the CRO realm. Last November, Minnesota-based Center Point Clinical Services launched a siteless CRO, which, like Parexel’s new offer, utilizes digital communication tools such as wearables to collect patient data.
Joe Martinez, CEO of Center Point, during an interview with FierceCRO at that time, said that digitally collecting data could also eliminate human errors, and he predicted that their wearables-plus-pharmacists model has a potential to save about 60% in clinical trial costs and an average of 10 to 12 months in terms of time needed for clinical trials.