Wearable devices are an essential part of our everyday lives. If you don’t own an Apple Watch or a Fitbit, chances are you know someone who does. While we typically use these devices for everyday activities and day-to-day routines, wearable technology holds the key to the future of healthcare.
In the world of clinical trials, wearables promise significant strides in data collection, patient insights, and smooth trial operation. Speed and efficiency, while crucial to running a successful trial and obtaining accurate data, present numerous issues. Wearables, despite their novelty to clinical trials, are helping to ease these issues.
For more insight into the growth of wearable technology in clinical trials, we spoke with Marcus Grindstaff, Chief Operations Officer of Care Innovations, a company that provides technology-based healthcare management services. Care Innovations deploys wearables and other home-based biometric devices throughout the US and Canada.
Wearable technology is an “angel on the shoulder.”
Patients are in a difficult position when they decide to participate in a clinical trial. When it comes to accessing healthcare, it’s common to hear patient stories like this: Wake up super early, get in the car or on public transportation, travel an absurd amount of time to the doctor’s office, have some tests run, and make the whole reverse trip back home.
In addition to issues of travel, patients have to fill out paperwork, stress over remembering to take medicine, and provide additional confirmations throughout their day. All of this can be scary and time-consuming, especially to someone who’s never participated in a trial before.
Bottom line: clinical trials for patients can be a pain.
Grindstaff says that, because of all these hurdles that patients face, the best kind of healthcare centers are the ones that operate in the backgrounds of patients’ lives.
“What makes wearables so magical is their continuous passive nature,” he says. “It’s like an angel on your shoulder who’s constantly watching.”
How do patients benefit from wearable technology?
Wearables make life easier for patients in several ways. They take away the burdens of participation in clinical trials. Since they’re passive, they become part of patients’ lives. A patient can go about their daily routine without being interrupted by the tasks associated with the clinical trial itself.
In addition to eliminating the physical and mental burdens of trials, the data the wearables collect across the study population gives insight back to patients.
“Patients aren’t just contributing to the study, they’re getting something out of it,” says Grindstaff. “It becomes a two-way street. It gets people more engaged in the process of their own care.”
By giving them real-time feedback, patients become more aware of their how they’re progressing through the trial. Taking drugs and going to the doctor is less individualized with little room for patient participation. With wearables, patients are actively involved in the care process.
How do researchers benefit from wearable technology?
Two important factors make wearables desirable to researchers.
The first factor is that wearables provide continuous monitoring. Traditional mechanisms are not continuous. For example, diseases that require any traditional electrocardiogram (ECG) mechanism, such as atrial fibrillation (AFib), take ECG samples on a periodic basis.
If that same patient with AFib uses a wearable, however, their heart’s data is continuously transmitted to the researcher. If the patient experiences a rhythm issue, that event will immediately show on the data feed. Even if the event happens once every two months, with continuous monitoring, anomalies are always visible.
The second factor is that reducing patient burdens is just as important to researchers as it is to patients. Since a continuous data feed is streamed from the patient to the site, patients don’t need to come on-site as often. According to Grindstaff, this means they’re far more likely to stick with the trial.
“Researchers don’t have to over-enroll as large of an amount. They’ll also have study subjects with better data through the trial. When you put those two pieces together, you get patients enrolled faster and you retain more patients in the trial,” Grindstaff says.
The significance of these two factors is clear. Trials can be started, operated, and completed at a lower cost, and access to care improves for all parties involved in trials.
Even though wearable technology sounds good on paper, there are still numerous hurdles to clear before fully implementing them in clinical trials – for patients and researchers.
It may seem obvious, but companies looking to use wearable technology in their trials must have existing technology and processes in place – infrastructures that can accurately and effectively deploy the wearables, track their data, and identify and address issues.
While traditional bookkeeping practices in clinical trials are well-established, an even higher bar exists for wearable technology in terms of operations and precision. Similar processes are still in the drafting stages, and comfort level within these processes still needs time to grow. Grindstaff notes that companies like PRA Health Sciences play an essential role in these processes. They take strategic steps to advance their technology forward based on years of delivering clinical trials.
“We need to intersect the well-established clinical trial operational model and evolve it to use new capabilities that exist,” says Grindstaff. “We need to build on top of history.”
An organization may have the means to collect the data, but another challenge for wearable technology is clinical validity of data. All data that is collected and aggregated needs to be both clinically validated and have proven integrity from source through to submission.
While it can still be a challenge to get wearables up and running, they are here to stay – and they’ll keep getting better.
What does the future hold for wearable technology in clinical trials?
Current wearable devices are just scratching the surface of what’s measurable and applicable. Wearables have certainly proved their validity and integrity enough to be used in trials, but researchers are looking to do more.
Grindstaff says dozens more parameters would be helpful to measure with wearables – more sophisticated ECGs, heartrate and heartrate variability, blood pressure, and blood sugar, to name a few.
Some parameters cannot be measured by wearables yet, but wearables can work in tandem with other upcoming technologies, such as in-home sample collection systems. For example, wearables provide parameters such as activity, blood sugar, cardiac rhythm and temperature, which all provide context for in-home sample collection.
Wearables are the critical element of driving virtual, decentralized trials. They bring high compliance, accurate measurements in the home, and reduced study site visits for patients. All of this is done in a simple, passive way for the user. Though wearables are still in the process of being adopted by researchers and companies worldwide, they will continue to play an integral part of a much larger developing story.
PRA Cool Under Deadline Pressure
PRA was selected to perform a Phase II colorectal cancer trial due to our knowledge from previous colorectal studies as well as our evidence-based…
Clinical Trials in Children with Impaired Mental Capacity
Download this resource to learn how to conduct studies with patients who lack legal competence and the 4 ethical pillars of medical research.