This case study explores one company’s challenges with this most widely used COVID-19 test methodology.
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What’s the first thing that pops into your mind when you hear the word “clinical trial”? You might think of being poked and prodded at a medical facility in the name of science, but clinical trials are looking much different, thanks to the use of wearables. In 2016, the U.S. Food and Drug Administration noted that the wearable devices could provide robust insights in trials, and signaled a willingness to allow researchers to use consumer-grade wearables to collect data.
While exercise trackers are the most widely known wearables, the wearables that clinicians are using are more sophisticated and track more than basic biometric information.
“This could be collecting information from the body itself or from the person’s activity. Wearables can also collect information or respond to conditions in the environment around the person. Wearables can be inward-looking, outward-looking or both,” says Dr. Albert Titus, chair of the Department of Biomedical Engineering at the University at Buffalo. The device then transmits the data to the researchers using technologies, such as Bluetooth or Wi-Fi, depending on the device.
Below are four benefits currently witnessed in clinical trials:
If you’ve led or participated in clinical trials, you know that they require a lot of coordination; finding a sample population, scheduling appointments for everyone, and closely overseeing procedures. While participants are paid for their time, often times, the money isn't enough to make the effort and inconvenience worth it for people to participate. Wearables reduce much of the data capture burden from participants, which can help with recruitment and retention.
Using wearables means that you get more accurate data faster. Trials using wearables inherently require fewer in-person visits with researchers because data can be collected 24 hours a day and automatically sent to the clinician. Unlike taking a “snapshot” of data during an appointment, collecting data by using a wearable gives a much broader, more accurate picture of the patient’s health because it's collected over the long-term. Common measurements include blood pressure, glucose levels, sleep cycles, heart rate and activity level.
We help bring to life all kinds of medical-grade wearables. These are smart, connected medical devices which combine digital health with consumer-friendly wearables. Examples of these applications include insulin patch pumps, smart pills which track patient adherence, the wearable injectors; thin, flexible sensor patches which can be worn directly on the body, and smart technologies that can be integrated into clothing. In the future, we expect to see widespread application of these technologies, including in clinical trials.
The best part? These devices enable patients and researchers to monitor progress through the submission of data feeds without the need for frequent office visits.
Wearable devices can collect data that are not otherwise possible to collect. For example, in trials involving sleep, wearables can help researchers test hypotheses that were not previously possible, such as how variations in sleep affect a participant’s activity or blood pressure the next day.
Another example is a recent clinical trial for Parkinson’s disease. Because small changes in movements can be hard to track, researchers used wearables to help find the right dosage of a drug to give patients. Participants used a finger sensor during two office visits to measure specific motor tasks related to Parkinson’s disease symptoms such as tremors, bradykinesia (slowed movements) and dyskinesia (involuntary movements). While at home, participants wore wrist and ankle sensors that used a cell phone for monitoring their symptoms throughout their daily activities.
Security and privacy are often top concerns with patients and researchers. Protecting patient data in our digital world is mission critical and by setting up the necessary security and privacy policies and procedures, wearables can be a secure means of transmitting information. If you’re using wearables in your trials, be sure to educate participants on security best practices, such as using strong passwords and keeping both the network and wearable security software up-to-date. It’s also important that the cloud infrastructure hosting the data is built and certified to manage regulated healthcare data.
Any data passively collected needs to have a purpose, as Premdharan Meyyan, a consultant with Fuld + Company, points out. “Data from these trackers can be transmitted, in real-time, back to the physician for monitoring purposes. But we still have to ask ourselves, ‘How useful is this information?’ In other words, does this data provide any meaningful insight into the safety and efficacy of the treatment, or is it merely information that is nice to know?”
Our BrightInsight solution is a medical-grade Internet of Things platform that integrates data from wearables, connected medical devices and therapeutics to deliver real-time intelligence for pharmaceutical and medical technology companies in clinical trials as well as commercial settings. We built the platform from the ground up to go beyond simple connectivity solutions to minimize our customer’s cybersecurity, privacy and regulatory risk.
We have implemented over 50 privacy policies and procedures to safeguard information, have deployed automatic processes to decouple sensitive personal information from other health data, and more.
Privacy policies implemented to protect patient data and information
In the Clinical Pharmacology and Therapeutics article “Wearable Devices in Clinical Trials: Hype and Hypothesis,” authors Elena S. Izmailova, John A. Wagner and Eric D. Perakslis suggested wearables are most helpful in clinical trials that positively affect patient's quality of life. If the trial is able to shed light on conditions underlying the patient's behavioral patterns and educate them on how to improve, that's an ideal scenario.
Let’s take the example of VitalPatch®, an IoT biosensor that monitors eight biometric measurements continuously, in real time. It sends vital sign data from heart rate to skin temperature, giving caregivers and clinicians powerful insights into the connection between a patient’s activities and biometric readings. It detects falls, heart rate, ECG, respiratory rate, body posture, skin temperature, heart rate variability and activity, enabling access to data previously unavailable.
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