Wearables: An Essential For Decentralized Clinical Trials

By Dan Schell, Chief Editor, Clinical Leader

Recently, while talking with Joe Dustin, the topic of wearables being used in clinical trials came up. As is the case when you talk with Joe, he knew someone that he recommended I speak with who had a lot of experience working with wearables. That’s how I got connected with Bryan Hansen, Ph.D., director of Innovative Health at Johnson & Johnson Innovative Medicine.

Joe wasn’t kidding; Hansen was a wealth of information on the topic. In fact, his answers were so thorough, I decided to break up this article into two parts. Here in part 1, he discusses types of wearables, his experience using them in neurological disease trials, and some future plans for these devices. In Part 2, he discusses advantages and challenges in addition to the types of personnel you need to execute a trial with wearables.

Dan Schell: Some of the most common types of wearables used in clinical trials include smartwatches, activity trackers, continuous glucose monitoring (CGM) devices, and wearable ECG monitors. Which have you used for your trials, and are there any others not on this list that you’ve used?

Hansen: I have leveraged all these technologies, drawing on our extensive experience with smartwatches and activity trackers. These devices represent a crucial passive data stream that not only provide continuous, real-world insights into participant behavior, activity, and physiological parameters but also enhance the contextual understanding of other active digital measures, such as cognitive testing, speech/linguistic biomarkers, and traditional in-clinic assessments. This contextual layer enriches the interpretation of clinical and patient-reported data.

In addition, I have also explored sleep measurement devices to get insights into sleep patterns and circadian rhythms, and off-body sensors, to reduce participant burden while maintaining high-quality continuous monitoring. Our approach emphasizes integrating multiple streams of digital and traditional data to create a comprehensive picture of patient health. By doing so, I can better support clinical trial objectives and ensure patient-centricity.

Moreover, it's essential the community engage in a meaningful conversation about clinical versus consumer wearables. There are distinct trade-offs, especially concerning battery life and access to raw data. However, the translation of this data and its impact on real-world evidence necessitate the use of these devices by tens of thousands of users, allowing for a diversity of applications that is often just a dream for many clinical-grade device companies.

Dan Schell: Have you found one TA that is a really good for incorporating wearables?

Hansen: While my background primarily lies in neuroscience, I acknowledge the bias inherent to that perspective. Neuroscience, however, stands out as a therapeutic area that greatly benefits from the incorporation of wearables due to the limitations of current subjective and infrequent endpoints and biomarkers. These challenges have historically contributed to high failure rates in trials, as traditional methods often miss the nuances of neurological diseases. This creates a strong need to gather more objective data to support better-informed clinical decisions. Furthermore, the shift from merely treating symptoms to implementing disease-modifying approaches demands a precision and understanding that current clinical or cognitive biomarkers simply cannot provide.

In neuroscience, wearable devices have been particularly useful for tracking motor function, sleep patterns, activity levels, and even cognitive or behavioral changes, offering a more dynamic understanding of disease progression and treatment impact.

In addition to neuroscience, immunology is emerging as another area where wearables are increasingly valuable. Immune-mediated diseases often have systemic effects that are challenging to monitor consistently using traditional approaches. Wearables such as activity trackers combined with sleep measurements enable real-time, longitudinal data collection that can provide deeper insights into disease activity and treatment response.  

Dan Schell: Do you have plans to use more wearables in the future?

Hansen: Without hesitation, wearables are a critical component of clinical trial design and play a central role in facilitating a thoughtful and innovative decentralized clinical trial strategy. As an industry, if we aim to transition from traditional sites to models that allow participants to engage from the comfort of their living rooms, reducing the burden of in-person visits, and making participation more accessible. For this, we must find effective methods for capturing passive activity and behavioral monitoring.

Wearables allow researchers to monitor participants in their natural environments, yielding insights that are often more representative of actual patient experiences than in-clinic assessments. As wearables continue to advance, I am committed to staying at the forefront of this innovation, ensuring our trials are scientifically rigorous and also aligned with the evolving expectations of patients and regulators.

Note from Bryan Hansen: “The views expressed in this article are my own and do not necessarily reflect those of my employer or any affiliated organizations.”