Pros & Cons Of Using Wearables In Clinical Trials

By Dan Schell, Chief Editor, Clinical Leader

After I talked with Lauren Sunshine, director, product management, Digital Health, at BMS for the January 2025 article, “Why Aren't We Using More Wearables In Clinical Trials?,” I was still curious about the use of these devices in trials. Eventually, I was connected with Bryan Hansen, Ph.D., director of Innovative Health at Johnson & Johnson Innovative Medicine, who was super helpful in answering all of my questions. The following is part 2 of the correspondence I had with Hansen. Click here to check out Part 1 where he discusses types of wearables, his experience using them in neurological disease trials, and some future plans for these devices.

Dan Schell: What are the biggest advantages of using wearables in a trial?

Hansen: The enhanced contextualization of patient data and behavior — such as the implementation of sophisticated at-home electroencephalography (EEG) and tablet-based cognitive testing — provides a comprehensive (near complete) view of patients and their disease state. However, a question remains: what is happening between these assessments?

By enabling continuous monitoring of physiological and behavioral parameters, wearables bridge the gaps between periodic assessments. When combined with applications that monitor cognitive aspects more frequently, the integration of wearable devices offers valuable insights, e.g., how sleep and activity influence performance in various disease states. This dual approach of integrating active (e.g., cognitive tests) and passive (e.g., activity tracking) data allows us to narrate a complete story; relying on just one aspect (either active or passive data) leaves clinical teams yearning for additional information.

Moreover, the potential for safety monitoring is particularly promising. For instance, wearable ECG monitors can detect early signs of adverse events, such as arrhythmias or changes in vital signs, allowing for timely intervention. This is particularly important in trials involving high-risk populations or treatments with complex safety profiles. As I explore opportunities to expand the use of wearables, I believe this aspect deserves significant emphasis.

Dan Schell: What is the biggest challenge of using wearables in a trial?

Hansen: As a field, digital health, including the use of wearables technology in trials, has faced challenges in clearly articulating its value proposition. Initially, the community asserted that the introduction of these approaches would result in shorter, more efficient trials with more objective data for clinical decisions. However, while the field has made progress, I believe we have yet to achieve this at scale.

One of the biggest challenges is the complexity of managing and analyzing the vast amounts of data generated by wearables. It necessitates a specialized group of data scientists, a robust IT infrastructure capable of securely processing, storing, and integrating wearable data with other trial datasets and analyzing the volume and velocity of data. Without these foundational elements, the potential of wearables can remain untapped. In addition to infrastructure, there are operational hurdles. Sites and patients often require additional training to ensure proper use of wearable devices and accurate data collection. This can add complexity to trial operations and increase the initial onboarding burden. Furthermore, the cost of wearables — both in acquiring the devices and maintaining the systems to support them — can be significant, particularly for smaller studies or those with limited budgets.

Another aspect is the narrative. When compared to other emerging technologies, such as GenAI, the value proposition of wearables can feel less direct to leadership. When I observe how GenAI has been presented to the industry, the narrative is much more straightforward. For example, for the adoption of LLMs the message is clear: utilize LLMs to assist in authoring protocols, which leads to fewer personnel involved in writing them — resulting in a reduction in headcount or an expansion of roles with added responsibilities. This simplicity in messaging makes it easier for leadership to grasp and adopt.

For wearables, the value they bring is broad and multifaceted (e.g., enhanced data quality, improved patient engagement, real-world insights, operational efficiency). This complexity can make it harder to clearly communicate their benefits to different stakeholders, from leadership to trial sites.

Dan Schell: How does the addition of a wearable in a trial change the makeup of the team as compared to a trial with no wearables?

Hansen: There is a need for representation from data science and digital health, data management, and possibly IT; however, the decision to include a wearable is made by the clinical and trial leads, who incorporate aspects like protocol writing, budgeting, and vendor management into the trial operations.

As technology continues to improve and evolve, and as a new generation of trial leaders enters this space, the reliance on specialized groups and individuals will diminish. Advances in wearable technology, along with better software tools and streamlined processes, are making these devices easier to implement and manage. The hope is that these approaches involving wearables will become just another aspect of a trial, as routine and seamless as any other biomarker.

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."