Six years after Pfizer's landmark REMOTE trial, soon-to-be bought out Parexel and French pharma Sanofi are teaming up in a pilot study to revisit the idea of using wearables in clinical trials.
The pair has launched a pilot study to test-run Parexel's recently launched “Patient Sensor” program. In this single-site study, the companies are collecting patient data remotely via multiple wearable devices, with the goal of examining how those data can be channeled into a single, scalable system for analyses.
In late March, Parexel launched the “Patient Sensor” solution via its own cloud-based clinical trial management and analytics system Perceptive MyTrials. It can capture, transmit, store and monitor data, as well as generate alerts for clinical trials. The aim is to increase patients’ ability to participate and engage with clinical trials, and to create more opportunities for decentralized trial sites.
Six years have passed since Pfizer pioneered the practice in its milestone REMOTE trial conducted in 2011. The study was the first to completely rely on web-based technologies to recruit patients and collect study data. Pfizer terminated that pilot program in 2012 due to low enrollment—at least partially caused by the study process’s complicated nature—but it was still the first remotely monitored trial that tried to test the method’s feasibility.
Technologies have evolved dramatically in those 6 years, and digital devices and online services have become more accessible. Perhaps the timing is right for Parexel and Sanofi to revisit the concept.
“[W]e 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,” said Xavier Flinois, president of Parexel Informatics, in a statement.
In fact, Sanofi is no stranger to remote online clinical study. Collaborating with Scotland’s trial tech company eClinicalHealth, healthcare-focused U.K. ad firm Langland and Finnish healthcare tech firm Mendor, last year Sanofi successfully completed a phase 4 study dubbed VERKKO, which tested Mendor’s 3G-enabled wireless blood glucose meter in remote clinical trial settings.
Parexel and Sanofi did not disclose the details of their pilot study, but Lionel Bascles, Sanofi’s global head of clinical sciences and operations, said in a statement that the Big Pharma is “committed to further advancing the potential of this technology.”
As for Parexel, rumors about a possible $4 billion sale of the CRO emerged last month, and soon after that, activist investor Starboard Value announced that it had purchased a 5.7% stake in the company, while also hinting a possible sale in an SEC filing.