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Over the past decade, clinical trials have undergone a fundamental shift. Therapies are more personalized, endpoints have more nuance and regulators increasingly expect evidence that reflects how patients function in daily life. Traditional, site-based assessments can no longer keep pace, often missing the dynamic changes that determine whether a therapy works.
In response, clinical research is moving toward continuous, real-world data collection enabled by wearable devices and remote monitoring. These tools reduce participant burden, eliminate artificial clinical settings, and provide a more accurate view of patient health over time. By capturing subtle physiological changes and long-term trends, wearables are helping researchers generate stronger evidence while accelerating development timelines and reducing overall trial costs.
This shift is already well underway. According to ClinicalTrials.gov, approximately 408 trials incorporating wearable devices began in 2025, accounting for more than 5% of all registered clinical trials. In 2015, that figure was under 1%. In just 10 years, wearables have become five times more prevalent in clinical research, spanning therapeutic areas such as cardiology, oncology, neurology, sleep health, migraines, long COVID-19, and stroke recovery. These trends point to growing confidence in wearable-derived data as a foundation for clinical decision-making.
In this blog, we will cover:
One of the strongest advantages of wearables is their ability to collect uninterrupted data over extended periods, giving researchers a more accurate representation of how patients feel and function in everyday life. Continuous monitoring allows researchers to detect transient or infrequent events that traditional short-term assessments often miss. Conventional technology like the 24-hour Holter monitor is limited to episodic measurements that can underestimate clinically meaningful signals, particularly for conditions that fluctuate over time, like arrhythmias.
Modern, wearable devices can also expand data collection, simultaneously capturing activity metrics such as steps, gait, and mobility, alongside physiological measures. When these data streams are time-synchronized and analyzed together, they offer deeper insights into patient health.
Wearables also play a critical role in addressing one of clinical research’s longstanding challenges: recruitment and retention. Clinically validated, FDA-cleared devices are a cornerstone of decentralized clinical trials (DCTs), which allow participants to take part from home rather than traveling to study sites, leading to reduced travel, greater comfort, and enhanced data collection.
Survey data underscores the impact of this model. In a Vivalink survey of over 200 U.S. adults, 90% said they were open to participating in fully remote trials, and 52% reported being very likely to do so, compared to just 34% for in-person trials. By removing geographic and logistical constraints, decentralized trials can better reflect real-world demographics, leading to findings that are more generalizable and clinically relevant.
Safety is central to clinical development, both during trials and after therapies reach the market. Wearables strengthen safety monitoring by enabling near-real-time data review and earlier detection of adverse events.
This capability is particularly valuable in high-risk populations. For example, continuous body temperature monitoring can help identify neutropenic fever, a serious chemotherapy side effect that affects around half of patients undergoing treatment. Remote patient monitoring devices like Vivalink’s continuous temperature monitor present an opportunity for earlier detection, allowing for faster intervention and improved outcomes.
Wearables can also shape safer, more effective therapies for future patients. In an ongoing atrial fibrillation study, early wearable data from our ECG patch revealed that individuals with frequent premature atrial contractions may be at higher risk of developing AFib. This insight allowed researchers to create new subgroups mid-study, expanding clinical understanding while the trial was still in progress.
By lowering costs, reducing participant burden, improving data quality, and enhancing safety, wearables have established themselves as a powerful tool in modern clinical trials. At Vivalink, wearables are already a cornerstone of heart health management; and as adoption grows, the supporting infrastructure is expanding alongside it.
From clearer regulatory pathways and validated digital endpoints, to interoperable software platforms and secure systems, these advances have moved wearables beyond feasibility and established them as a standard for modern clinical trial design.
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