Decentralized clinical trials (DCTs) continue to grow in popularity. As they do, they reshape how sponsors and CROs think about patient access, data collection, and operational efficiency. A chief concern is the need to ensure reliable data, a must for maintaining regulatory compliance and validating the study. Without the safeguard of the direct supervision found in research sites, maintaining the integrity of data collected from trials becomes a challenge.
Ensuring that remotely collected data is as accurate and consistent as in-clinic data is a critical challenge to overcome. The introduction of variable environments and behaviors puts data at risk, potentially leading to fragmented, high-volume data that can lead to errors, gaps, or inconsistent records. Keeping that data consistent requires intentional design across device selection, participant onboarding, and data monitoring, supported by medical-grade tools and standardized workflows.
DCTs are popular because they allow trials to take place outside of traditional research sites such as hospitals or clinics, participants are able to complete the trials with little to no travel, often in the comfort of their own homes. By improving patient convenience and accessibility, offering an expanded data collection, and reducing the time needed for travel, DCTs can revolutionize the way sponsors conduct trials. Not only can they encourage more people to participate and increase retention in long-term studies, but they can also help trials better reflect the general population.
At Vivalink, we’re working to improve clinical trials and ensure reliable results. From selecting devices that meet regulatory standards and provide accurate readings, to supporting participant adherence to maintain data integrity, we’ve put together our advice for designing remote trials for reliability.
In this blog, we will cover:
Clinical research depends on data integrity, so ensuring reliability in DCTs is non-negotiable. When participants are removed from direct supervision, maintaining that reliability and integrity becomes complicated. As required by the FDA, any device used in research must produce accurate and secure data that aligns with traditional tools, meeting the same data quality and validation standards as in-clinic systems.
At Vivalink, we ensure reliability through continuous data provided by our wearable devices, which offer a more accurate reflection of a patient’s day-to-day reality. These remote patient monitoring (RPM) devices significantly improve data quality, detecting subtle changes that might otherwise go unnoticed between clinic visits, demonstrating the ability to capture heart rate and respiratory rate as well as in-hospital clinics do.
So how do we ensure data integrity for DCTs? We start with having the right devices.
Selecting a medical-grade device is essential, as they meet the strict standards for accuracy, data security, and regulatory compliance. Consumer-grade devices often become “black boxes” where data is automatically transmitted to the manufacturer's proprietary cloud servers. Researchers are unable to see how the data is processed or verify its state, leaving room for uncertainty and errors. The lack of ability to validate data is a quick way to run up against FDA regulations, which require that devices be validated for their intended use. Medical-grade systems must provide researchers and auditors with transparency into how they collect data and interpret it, instead of hiding it behind proprietary algorithms or manufacturer clouds. By providing unlimited access to data, we can transform the “black boxes” into “glass boxes” that allow for transparency and validation.
Equally as important as choosing the right device is using it correctly. The technology used for trials should be simple, intuitive, and easy to set up. Making sure devices are unobtrusive, lightweight, and comfortable to wear helps them fit into patients’ daily routines, ensuring long-term adherence. Ongoing support is just as important: by providing continuous monitoring and proactive check-ins, you can improve both patient experience and the overall quality of data. This support is a significant factor we keep in mind when building Vivalink’s wearable devices, further supporting reliability in remote trials.
Once the data is collected, it needs to move securely and consistently into a centralized system. Fragmented data can lead to delays, errors, and blind spots, so having a unified data ecosystem (typically a cloud-based one) is critical. By backing that system up with real-time adherence monitoring and alerts, researchers can intervene quickly if needed, and data is kept accurate and protected.
Before you move towards adapting remote trials, it pays to build the groundwork for reliable results. By prioritizing medical-grade tools and transparent oversight, researchers can achieve results that stand up to regulatory scrutiny and improve reliability. To learn more about designing trials for reliable data, contact Vivalink today.