Why Aren't We Using More Wearables In Clinical Trials?

By Dan Schell, Chief Editor, Clinical Leader

There’s a problem with using wearables in clinical trials.

Namely, we aren’t using them enough.

Yes, there are plenty of other challenges, but that first one really bothers Lauren Sunshine, director, product management, digital health, at BMS. “Honestly, I think it’s sad how long it has taken for wearables to catch on in clinical trials,” she says. “Part of the slow adoption is that pharma companies aren’t collaborating. For example, if all Big Pharmas contributing their data to build out a validated measure for a TA like fatigue, then we probably would’ve already had something that was approved by regulatory bodies, and we wouldn't have to rely on the variety of subjective assessments that we’ve been using.”

ARE YOU EXPERIENCED?

As you would expect from someone with a title like hers, Sunshine is a DHT and wearable enthusiast, although she’s quick to note that these technologies aren’t simple to implement. You’ll need specialists, like computational neuroscientists or just a project or product manager who has experience deploying these solutions. Having that experience will help with a plethora of inevitable challenges you’ll face. Here’s a good example she discussed with me.

Say you decide to make it optional for participants to use a wearable in a trial. That’s great in terms of patient-centricity, but not so great when it some to your opt-in rate — which is likely going to be low. After all, a lot of participants may be intimidated by some type — or even any — tech. They also may be deterred because of how long they need to wear a device either daily or during the course of a trial. To combat all of this, you need someone skilled at crafting strong onboarding scripts for sites that help site personnel communicate the DHT’s value, so patients are encouraged to participate and feel comfortable using the tool. They need to understand how to strike that delicate balance between being helpful and being a burden when it comes to how frequently they follow up with sites about reminding patients to correctly wear a device for a trial.

Another example is related to something patients have been asking for even in trials not involving wearables — feedback on their performance/involvement at the end of the trial. Patients are interested in meaningful data such as their physical activity levels and how those changed over time during the study or simply how compliant they were with the study protocols. “We've heard from several investigators and patients who would be really interested in receiving this type of data,” Sunshine says. “And having that data would make them want to participate more in the portion of the study that includes the digital component.” Being able to provide that feedback loop, though, means you’ll need someone who has done it before and understands all the regulatory nuances associated with data access. Does the device have clearances in all the countries in which the trial is being conducted? If not, do you have someone who understands options such as investigational-use exemptions that you may be able to employ?

DHT EXAMPLES THAT COULD BE USED IN CLINICAL TRIALS

According to the FDA’s Framework for the Use of Digital Health Technologies in Drug and Biological Product Development, “DHTs may take the form of hardware and/or software. DHTs often consist of sensor hardware that allows for continuous or intermittent recording of physiological and/or behavioral data (e.g., blood pressure, physical activity, glucose levels).” The following are a few examples of some DHTs that use passive data collection that could be used both in clinical trials and as stand-alone therapeutics:

1. Social interaction and quality of life — Part of measuring quality of life for a patient with a chronic illness is understanding how much they might be interacting socially. Are they still getting out of the house and interacting with people? Are they interacting socially at all? Some companies are passively capturing this data by using the Bluetooth pings of a patient’s phone. The phone will elicit a ping when in close contact with another person’s phone.  
2. Vital signs — Those selfies you take with your phone could yield valuable data. There are now apps that use your phone’s camera to estimate vital signs such as heart, respiration, and blood pressure rates.
3. Movement predictions — Actigraphy sensors or gyroscopes embedded in smartphones/wearable devices aren’t a new type of DHT, but some companies are continuing to refine them to provide more feedback to patients for help with issues such as gait freezing or even falling. The devices can monitor and predict when a movement problem could occur and subsequently warn the patient (e.g., through an auditory tone) so they can react appropriately to possibly prevent the issue from happening.
4. Voice and speech analytics — DHTs are often being tested in the mental health field. One such application measures a person’s tone, pitch, and even type of verbiage to better help understand their mood and anxiety/depression levels over time.

Is there a wearable or DHT that can fit every trial? I doubt it. But Sunshine does believe that any TA could benefit from a DHT in a clinical trial. “Think about it,” she says. “Today, a lot of the data we’re capturing to understand how our treatments are impacting patients’ overall quality of life are highly subjective; usually collected via a PRO questionnaire. We’re asking patients questions like, ‘Over the past month or week how much pain were you in? How did you sleep? How tired were you?’ Most of us who aren’t suffering from a disease would find it hard to answer these questions, so imagine how difficult it is for an elderly patient who is prone to recall bias. Wearable devices that can passively collect this data while also offering regular feedback, reminders, and encouragement throughout a trial can be immensely helpful to a clinical trial.”