Brandy Chittester, chief of clinical operations, IMARC

Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns.

Here’s a look at how researchers are using wearable devices — and what you should consider before using them in your own research.

How wearable devices are advancing medicine

Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description.

This includes wearable devices intended for medical use, as well as testing other medical devices using wearable technology.

Here are just a few examples:

• A study evaluating the utility of Fitbit for diagnosing sleep apnea
• A study evaluating the feasibility of using Garmin watches to detect atrial fibrillation
• A study evaluating the feasibility of using a wearable device to improve arm movement in people who have had a stroke
• A study assessing the effectiveness of a wearable, automated bionic pancreas system that delivers both insulin and glucagon to young children with diabetes

Benefits of wearable devices in clinical research

Wearable devices can certainly benefit patients, but they can also offer many benefits to clinical researchers.

These benefits include:

• More convenient and less intrusive for participants, since participants can collect data in the comfort of their own home.
• Easier to identify a baseline for individual patients and show patterns over time, which can allow for more precise treatment
• The potential for a larger sample size, since it’s easier to recruit patients remotely
• More accurate results, since wearable devices can collect data 24 hours a day, seven days a week, and data is more objective than paper diary entries
• Researchers spend less time on data entry since data is collected in real time
• Researchers can identify and respond to adverse events more quickly.
• Data collection may be less expensive, depending on the devices used

Wearable devices in clinical trials: challenges and considerations

Using wearable devices can pose several challenges — including regulatory concerns and logistical issues.

A July 2018 report published in Clinical Pharmacology and Therapeutics called Wearable Devices in Clinical Trials: Hype and Hypothesis, outlines several of these concerns.

Many wearable devices are not medical devices

Although the Internet of Things offers enormous potential for smart, wearable medical devices, many wearable devices do not undergo the same rigorous regulatory process as other medical devices. Many make health claims that are not substantiated by the FDA or any regulatory board.

For instance, doctors have expressed concerns about some wearable devices intended to monitor a baby’s vital signs. Many of these products have not been evaluated by the FDA, and doctors say they can generate false alarms and even lead to unnecessary tests on otherwise healthy infants. Using devices like these in a clinical study that must adhere to FDA regulations could potentially be problematic.

There are also concerns about using wearable medical devices in drug trials since the approval process is different for drugs versus devices.

Challenges with processing data

Most clinical researchers are not accustomed to processing the massive amounts of raw, unfiltered data that is collected via wearable devices. They need to be able to eliminate invalid data, understand which sets of data are required to maintain an audit trail, and which data should be reported as a final result.

There may also be differences in how data is recorded and stored from one device to another, which can create consistency issues.

Ethical and legal challenges

While data obtained by medical devices is protected by patient privacy laws (HIPAA in the United States), those same protections don’t apply to consumer-grade wearable devices like fitness trackers.

Data obtained by consumer-grade devices may contain private health information that can be shared in an aggregate form without explicitly stating who will have access to it.

However, in the European Union, the new General Data Protection Regulation (GDPR) does not distinguish between device type. It requires that all data generated by wearable devices or apps have clearly defined purposes for use. Users must consent to have their data from these devices reused, and they may withdraw their consent at any time.

What’s next for wearable devices in clinical trials

Researchers considering the use of wearable devices in clinical trials need to recognize these factors as they develop their study protocol and conduct risk assessments.

They will need to determine what types of wearable devices are acceptable to use and understand how different device types could impact data collection.

They need to ensure patients understand how to use these devices properly and clearly outline expectations for when and how to wear them during the study.

Additionally, researchers may need to update disclosures and consent forms so patients fully understand what data is being collected, how it will be used and how any personally identifiable information or private health data will be protected.

Our team is excited about the potential for using wearable devices in clinical research, and we have relevant experience in this area.

If you are interested in using wearable devices in an upcoming clinical trial, contact us to learn more about how we can help you achieve compliance and earn approval.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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