Wearables are improving the clinical trial experience for patients and satisfying the need to collect data for real-world use studies. In this interview, ERT’s Karin Beckstrom provides insight into how wearables are being used in clinical trials today, and what the future has in store.
How can wearables be used in clinical trials?
As more and more sensors are built into wearable devices, their usefulness in clinical trials increases, as they can provide more data types and greater ease-of-use for patients. Wearing a bio patch can provide detailed information on muscle capabilities, wearing sensors built into clothing can provide respiratory and cardiac data, shoe inserts can track gait and steps, jewelry can unobtrusively provide sleep data, even our ear buds can be embedded with sensors.
Companies are even coming closer to capturing blood pressure data through a wearable device.
This breadth allows for real-world evidence across all clinical trial phases. A key part to using wearables is understanding the context of the data. For example, if you see a high heart rate for a period of time, does that indicate the patient was in distress or they were jogging on a treadmill at the time? Combining PRO (patient reported outcomes) data with wearable data provides contextual accuracy.
What are the most common devices used in clinical trials?
The two most common requests we have receive are connected; using wearables to track activity and sleep data. Multiple types of wearables can track this data, distinguishing when a wearer is sleeping, resting, sedentary, performing low, moderate or vigorous activity. This provides useful insight across a variety of therapeutic areas. Gait information is also commonly captured to measure stride, stability, and falls.
We also see where trials are shifting from sporadic measurements to continuous, such as using continuous glucose monitoring (CGM) instead of a standard glucometer. As this trend continues, we will also see an increased use of Artificial Intelligence (AI) / machine learning to identify both trends and anomalies.
What are the advantages of using wearables in clinical trials?
There are dual advantages to using wearables in clinical trials, First, you collect data from patients in their real lives which helps to better understand the efficacy and impact of the drug in the real world. That data is important to both regulators and payors. Secondly, wearables provide enough data to identify meaningful trends. For example, capturing walking speed during a patient’s real life provides a truer measure than conducting a 6-minute walk test in the clinic.
Clinical trial sponsors can identify small but meaningful improvements over time due to the quantity of data collected. These quality and quantity advantages explain why more trials are including the use of wearables.
What regulatory considerations do companies need to take into account?
The FDA has been very supportive of the use of wearables and more broadly digital health in clinical research. They are actively creating and implementing regulatory policies and strategiesto support their use in clinical trials. But that doesn’t mean pharmaceutical companies have a pass from all regulations. Data collected must still meet the standards for open systems and electronic records as defined in 21CFR part 11.
EMA has also been encouraging digital health initiatives, in fact the IMI’s public/private partnership in the EU has a project to validate real world walking speed as a clinical endpoint. Again, even with this encouragement, traditional regulations still apply to data collection and special consideration needs to be given to GDPR and ensuring the wearables follow the privacy by design concept.
What do you see as the future use of wearables?
While we aren’t there yet, we are already seeing trends develop; for example, more multiple sensor devices, better application of algorithms and machine learning to provide valuable data from the sensor data, and ‘never off’ data capture. As I see it, the wearables industry is driving towards a single device capable of providing an overall health assessment, in real time, all the time.
Will wearables and mHealth enable “virtual” or site-less trials?
While the trend to enable greater and easier participation through virtual or remote trials is taking hold, the use of wearables and mHealth devices to collect real-world participant data is important in all types of studies. We call this a digital trial philosophy which is centered around four focus areas:
- Collecting (more) data directly from the source through wearables and mHealth tools
- Increasing dialog directly with patients
- Automating workflows for both participants and clinicians for easier navigation
- Aggregating and applying AI and data science to make participation in trials substantially easier and with better outcomes for patients, sites, and sponsors.
Implementing change can be difficult for the typically risk-averse pharma industry, but equally, inaction carries its own dangers. Companies that take the initiative to leverage new wearable technology in their clinical research will undoubtedly benefit from trials that generate broader, more continual and insightful data sets while, at the same time, seeing the burden that trial participation places on patients and investigators significantly reduced.
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Karin Beckstrom is a Senior Product Manager at ERT.