Verily Life Sciences, a subsidiary of Google’s parent company Alphabet, has unveiled a new smartwatch for clinical research that can capture round-the-clock health data for large-scale and long-term studies.

Although the investigational device, called the Verily Study Watch, is not available for sale, Dutch researchers will use the health-tracking watch in a multi-year Parkinson’s disease study that will begin enrolling patients in July. In addition, Verily launched a four-year observational study last week with Duke University School of Medicine and Stanford Medicine that will use the Study Watch to track daily health data from some 10,000 volunteers.

Verily released its research-focused smartwatch as technology companies—including Apple, Microsoft and Samsung—have become increasingly interested in the use of wearable sensors to monitor health and collect data to support drug development. Verily’s official announcement came just days after rumors emerged that Apple has hired a secret team to develop sensors designed to monitor glucose levels in diabetic patients and has been conducting feasibility trials at clinical sites in the Bay Area.

“Verily’s Study Watch has the potential to significantly improve the clinical trial patient-level data collection process,” said Jon Meyer, co-founder and principal, Life Science Strategy Group. “Ideally, the new watch should enable remote health monitoring with improved data integrity and patient compliance, while potentially reducing costs. We are now at the intersection of Big Tech and biopharmaceutical development. The watch can serve as a proxy for how Big Tech can help facilitate the development of innovative medicines.”

Although there are already many wearables on the market, Verily designed its Study Watch specifically to address the needs of clinical and observational studies. The team took into consideration the impact that continuously wearing a tracking device could have on a volunteer’s experience and willingness to participate. The design and functionality decisions included a sleek, simple look that people would feel comfortable wearing daily, even for multi-year studies; battery life of up to one week and the ability to store a week’s worth of raw data, reducing the need to frequently charge and sync the device; and the ability for study participants to upload data without the need for computers or Bluetooth devices.

Sensors on the Study Watch measure signals including heart rate, movement data and electrodermal activity. An element that sets the Verily Study Watch apart from most other wrist-worn health trackers is its ability to collect an electrocardiogram (ECG). In addition, all health data stored on the watch are encrypted for security. The encrypted data are uploaded and processed in the cloud using Verily’s backend algorithms and machine learning tools, a feature that can be scaled to serve population studies consisting of large volumes of data.

The smartwatch will be used in the Personalized Parkinson’s Project, for which Verily is collaborating with Radboud University Medical Center, Radboud University and
ParkinsonNet, a network comprised of 3,000 medical and allied health professionals treating people with Parkinson’s disease in the Netherlands. The two-year observational study will follow 650 patients to identify patterns in the progression of Parkinson’s disease and provide a foundation for more personalized treatments.

Bastiaan R. Bloem, M.D., Ph.D., medical director of the Parkinson Centre Nijmegen, which is part of the Radboud University Medical Centre in Nijmegen, the Netherlands, said data from the Study Watch, along with deep phenotyping and analysis of DNA, RNA, state-of-the-art brain scans, stools, cerebrospinal fluid and inflammatory biomarkers of the blood, will allow researchers to build personalized disease profiles.

“We are interested in tracking the disease carefully, over time, in the patient’s own home. The Study Watch will allow us to do that. For example, we can track the volume of physical activity and how that develops over time. We are very interested in sleep. We are also interested in heart rate variability, which is a sign of autonomic dysfunction and one of the core features of Parkinson’s disease,” said Bloem, who is also co-founder and co-director of ParkinsonNet. “We are going to grasp the whole range of domains continuously over time, which are difficult, if not impossible, to reliably capture in a clinic.”

As part of its contract for the Parkinson’s project, Verily has agreed not to de-identify or sell raw data. The study is also pioneering a privacy method called polymorphic encryption and pseudonymization (PEP), developed by Radboud University professor and digital security expert Bart Jacobs. The method ensures that parties working with the data can never combine data in the background because they all receive different keys. An independent third party, which has no access to the data itself, creates a separate pseudonym and encryption code for each patient and each end user.

“This privacy-by-design infrastructure, which we designed, has been hailed across the Netherlands as a new way to begin working with private companies,” said Bloem. “We have installed a new method that goes well beyond the Personalized Parkinson’s Project and that can serve as a model for other disorders, other companies and other research groups that want to share data.”

Verily is also partnering with the Duke University School of Medicine and Stanford University to use its wearable device in a longitudinal observational study called Project Baseline that will follow about 10,000 volunteers for at least four years. The study, which will include both people in good health and others who are at high risk of chronic disease, is designed to develop a reference map of human health as well as a data platform that can be used to better understand the transition of individuals from wellness to disease and identify additional risk factors for disease.

While many technology companies are experimenting with wearable devices for medical research, a recent Life Science Strategy Group study found that only a fourth of biopharmaceutical companies surveyed use wearable devices in clinical trials. The biggest challenge preventing further incorporation of this technology in clinical trials, according to the study, is validation of the devices and its use with specific study protocols.

“Long term, I believe the potential of wearable devices is, and will prove to be, a critical element in improving access to more, better quality, patient-level data, while potentially lowering overall trial costs,” said Life Science Strategy Group’s Meyer. “However, the biopharma industry is highly regulated and pharma can be slow to adopt innovative technologies that lack extensive validation. Ultimately, I feel that will be a key to the success of this watch—or any new wearable technology. With validation will come utilization and ultimately success.”

This article was reprinted from Volume 21, Issue 16, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »