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.
Hereâ€™s a look at how researchers are using wearable devices â€” and what you should consider before using them in your own research.
Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with â€śwearable devicesâ€ť or â€śwearable technologyâ€ť 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:
Wearable devices can certainly benefit patients, but they can also offer many benefits to clinical researchers.
These benefits include:
Using wearable devices can pose several challenges â€” 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.
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 babyâ€™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.
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.
While data obtained by medical devices is protected by patient privacy laws (HIPAA in the United States), those same protections donâ€™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.
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 authorâ€™s only and do not necessarily reflect those of MassDevice.com or its employees.
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