Sanofi and Parexel collaborate to study usefulness of wearables in clinical trials

By Heather Mack
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Life sciences consulting firm Parexel is teaming up with Sanofi to research the role of wearables in clinical trials. While sensor-enabled devices have increasingly featured in a variety of research projects and studies, their efficacy and accuracy remains a point of debate, and Parexel and Sanofi hope to investigate that question.

Together, Sanofi and Parexel are leveraging their respective clinical, regulatory, logistical and technical expertise to determine how wearables can optimize data collection and study performance, ultimately resulting in faster drug development.

“We believe the use of wearables to collect data from trial participants represents a breakthrough in the digital transformation within the industry,” Parexel Informatics President Xavier Flinois said in a statement. “Working with Sanofi, we believe we have a strong opportunity to streamline and automate data collection from multiple devices, collect high-quality data remotely and generate meaningful results, all while reducing burden on patients and sites, as well as lowering costs.”

Parexel, which is set to be acquired by private equity firm Pamplona Capital Management for $4.6 billion, has already been making moves to get deeper into wearable research. The company announced in March the Patient Sensor Solution pilot study, which uses Parexel’s Perceptive MyTrials analytics platform to remotely collect patient data from multiple wearable devices.

“Due to evolving regulatory and payer standards in today’s healthcare market, there is a growing need to leverage alternative data sources in clinical trials,” Flinois stated at the time. “Wearables and sensors have the potential to transform Phase I-IV trials as well as observational studies.  However, infrastructure and multi-functional expertise are needed to validate the appropriate use of medical devices to generate clinical and quality-of-life endpoints. Parexel’s offering could disrupt the industry standard of collecting data during site visits only, allowing biopharmaceutical sponsors to more easily demonstrate safety and/or efficacy and differentiate treatments from competition using remote monitoring approaches.”

The ongoing, single-site study with Sanofi will build on this project, which comes at a time when the wearable market is still projected to grow, according to IDC data. Additionally, an extensive report from Ericsson published a few weeks ago predicted that 5G connectivity will be increasingly important in healthcare as patients start to demand more connected care through wearables, apps, and telehealth. Wearables have also enjoyed increasing use in clinical research, even in spite of debates over their accuracy.

“Our objective is to demonstrate the relevance of data collected remotely and the overall feasibility of utilizing wearables in clinical trials,” Lionel Bascles, global head of Clinical Sciences and Operations of Sanofi, said in a statement. “Wearables are a core component of Sanofi’s digital trials strategy, and represent an important approach to automate patient processes using the latest technologies to bring new therapies to patients sooner.”

That’s definitely more involved than a recent wearable project Sanofi’s Consumer Healthcare division discussed in March of this year, wherein the company used wearables to track the sleep and activity of allergy sufferers in a small non-scientific test in order to demonstrate ways in which allergies can be disruptive to people's lives. Overall, the company told MobiHealthNews, that was more of a “social experiment.”