Contributed Commentary By Keith Wenzel

April 26, 2017 | The demand for wearables and sensors in clinical trials is on the rise. Pharmaceutical companies are increasingly challenged with both rising costs and the need to find novel ways to differentiate the drugs they are developing, and therefore look to CROs to help solve these problems, from a technology perspective as well as a process and scientific perspective. By leveraging remote medical devices, there is an opportunity to collect novel endpoints and supplemental data that may improve the regulatory case, make the case for reimbursement more compelling, open up participation to a wider population and/or reduce site visits for patients who may not live close to an investigative site.

A former partner was looking to add remote sensors to a Phase I trial as a means to begin their pilot of sensors as well as to compare the sensor data to the in-clinic data for a trial. We were able to collaborate on a design that minimized the impact on the core protocol while maximizing the number of devices. In all, we were able to add on six remote medical devices: spirometer, blood pressure, pulse oximeter, blood glucose monitor, weight scale and activity monitor.

In addition to Phase I trials, there is also a growing demand for this technology in Phase IV studies. This demand stems from both a post-marketing perspective, as well as their use in making the case to regulators that a drug should move to an over-the-counter status because the general population has the ability to use commonly available medical devices to either self-diagnose or monitor a particular health condition.

While it’s true that medical devices, such as spirometers and activity monitors, have been used in clinical trials for almost a decade, the difference lies in the growing number of devices with embedded technology. It used to be that the spirometer or activity monitor had to be taken back to the site and the data was either transcribed into an electronic data capture (EDC) system, which can introduce transcription errors, or downloaded. The latter, however, creates a data management burden for the site to ensure that all the data were downloaded and ultimately transferred to the clinical data management system.

What’s truly differentiating is the maturation of the technology. Medical devices can now securely and wirelessly transfer data, lowering the burden on both patients and sites, and increasing the integrity of the data. For example, once a reading is taken on a blood pressure monitor, that data is automatically downloaded to a hub (a device plugged into an electrical outlet). The patient then plugs in the hub once and takes his or her readings on the prescribed schedule. All of the data transfer is handled seamlessly and securely without the need for manual intervention. If the patient forgets to plug in the hub, the data is stored on the medical device until it’s plugged in. An alternative, but still secure data transfer mechanism is via a companion app on a smartphone.

While there is not specific formal regulatory guidance related to the use of the devices for study endpoints, at a Drug Information Association Meeting in December 2016, the U.S. Food and Drug Administration (FDA) expressed cautious optimism that these devices could provide better and more timely insight into a patient’s health status. FDA speakers went so far as to say that researchers need not necessarily use medical devices with a 510(k) approval or CE stamp; consumer grade devices can be used as long as they are “fit for purpose.”

The maturation of predictive analytics when applied to remote medical devices offers the potential ability to alert researchers to future safety events before they occur or to predict the more mundane, but still important task of identifying devices that have low battery or which might be failing so they can be replaced before failure occurs. This technology will allow remote and in-clinic data to be “fused” together for sites and study teams to view side-by-side in Phase I-IV clinical trials. The challenges will be storing the potentially large volume of time series data that the devices generate, and alerting and visualization of this data for study sites and study teams.

We are now receiving requests for proposals to use remote medical devices for Phase I to Phase IV trials. Some of these requests are even looking for a total outsourced solution, from device validation, acquisition and distribution, to protocol and informed consent authoring to data visualization, alerting and analysis. It’s rewarding to receive positive feedback and hear that study subjects have been willing and able to use this important technology.

Keith Wenzel is senior director at PAREXEL International. He can be reached at keith.wenzel@parexel.com.

Correction: The author's surname was misspelled. It is Wenzel, not Wetzel.