The landscape of clinical trials is evolving, and decentralized clinical trials (DCTs) are at the forefront. Unlike traditional trials that require in-person site visits, DCTs use digital health technologies to collect patient data remotely. In most cases, participants contribute data from home, reducing the need for frequent travel and minimizing reliance on site-based models.
Traditional clinical trials typically take place at a medical site, such as doctors’ offices, hospitals, and universities. For many patients, especially those with difficult schedules or living in rural areas, frequent site visits can be a barrier to participation. DCTs are just like their traditional counterparts, but instead utilize telemedicine, wearable devices, and digital tools to increase convenience and accessibility for both providers and patients.
Digital health technologies are fundamental for the success of DCTs, enabling real-time remote patient monitoring. Wearables, mobile health apps, and telehealth platforms allow researchers to collect continuous data, giving a more comprehensive picture of a participant's health outside of scheduled visits. Many remote clinical trials now incorporate wearable devices to track key health metrics, including heart rate, blood pressure, temperature, and respiratory levels.
For example, a recent study tested whether heart rate recovery (HRR) after submaximal exercise could be accurately measured at home using wearable sensors. Researchers had participants wear Vivalink’s ECG patch to track HRR remotely and then compared the data with hospital-based measurements. The findings showed that wearable technology can capture clinically valid data outside of a traditional trial site, reinforcing its role in decentralized trials.
With regulatory support and growing patient demand, the adoption of virtual clinical trials has only accelerated. The FDA has advocated for integrating digital health technologies in clinical trials. The agency issued guidance on decentralized trial design and implementing these technologies in research. The European Union (EU) has followed suit and issued recommendations for incorporating decentralized elements into clinical study design.
Accessibility & Diversity
A diverse patient pool is essential for producing study results that reflect a broader population. Traditional site-based trials often limit patient participation due to logistical and geographic challenges. DCTs expand access by using remote patient monitoring technologies, allowing more patients in rural areas and underrepresented groups to participate. As a result, DCTs ensure research captures differences in sex, race, or age for more representative results.
Enhanced Data Collection
Patient data is central to evaluating treatment efficacy. In traditional trials, periodic site visits create gaps that may miss key health fluctuations. DCTs, on the other hand, use wearables and remote monitoring to continuously track health metrics during a patient’s daily routine. These technologies provide real-time insights and more comprehensive data sets, giving researchers a clearer picture of how a treatment performs in real-world conditions.
Improved Patient Experience
Even with travel reimbursements or financial incentives, recruiting and retaining patients remains a challenge in clinical trials. DCTs remove many of these barriers by allowing remote participation, reducing the burden of site visits, and minimizing disruptions to daily life. This flexibility makes it easier to enroll and retain patients, leading to higher engagement and better study completion rates.
Cost & Process Efficiency
Traditional on-site processes require extensive coordination, staffing, and in-person data collection, which often lead to high costs and slower trial progression. DCTs optimize operations by reducing scheduled site visits, leveraging remote data collection, and minimizing on-site staffing needs, which can lower overhead costs and accelerate trial timelines.
DCTs are becoming a key part of the future of clinical trials, but widespread adoption depends on overcoming key challenges, including technology barriers and the need for well-connected systems.
Not all patients have reliable internet access or experience with digital tools. To ensure efficient data collection and maintain data integrity, sponsors should look for technology partners that offer user-friendly devices and strong technical support.
Successful DCTs rely on connectivity between devices, telehealth platforms, electronic health records (EHRs), and cloud-based data analytics. Without an integrated system, gaps in data can create inefficiencies and impact trial accuracy.
According to a Frost & Sullivan report, decentralized trials will require ongoing support from fit-for-purpose cloud-based platform solutions. Partnering with a technology vendor that provides both devices and a connected platform ensures interoperability, real-time data access, and greater trial efficiency.
DCTs need reliable real-time data to improve patient outcomes and drive efficiency. The right technology partner can make all the difference. Vivalink’s connected technology combines advanced wearables with a secure data platform to enhance trial efficiency and support diverse patient participation.
VivaLNK, Inc.
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Campbell, California 95008
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Support: support@vivalink.com
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