Decentralized clinical trials (DCTs) are reshaping clinical research by expanding patient access and enabling real-time data collection through remote patient monitoring (RPM) technologies. By reducing the need for frequent site visits and leveraging digital health technology, DCTs offer a patient-centric approach.
Despite these advantages, sponsors and researchers still face key challenges, including patient engagement, technology integration, and logistical hurdles. As clinical trials increasingly shift toward DCTs, researchers must address these obstacles and apply practical strategies to ensure trials run smoothly and deliver high-quality data.
Maintaining patient engagement in clinical trials can be difficult, with studies showing that dropout rates can reach more than 30%. While remote monitoring in clinical trials can increase patient accessibility, introducing digital tools can present new challenges.
Researchers often aim to have diverse participant pools to ensure accurate and representative results. However, certain groups, such as older adults and those in rural communities, may struggle with technology or feel disconnected from the study. These factors can worsen dropout rates, jeopardizing study progression and data integrity.
Implementing engagement monitoring, technical support, and user-friendly technology can help encourage patient participation and retention. For example, tracking adherence metrics can help researchers identify participants needing additional support. By providing clear instructions and technical support, researchers can help alleviate patient frustrations with digital tools.
Maintaining data integrity is a priority in clinical study design, and remote patient monitoring tools have proven to be reliable in tracking key health metrics. For example, a recent study comparing the data accuracy between Vivalink’s cardiac patch and an in-hospital ECG-based monitoring system showed that the wearable device was just as accurate as the hospital system for tracking both heart rate and respiratory rate.
Despite their reliability, remote patient monitoring generates large amounts of data that researchers must analyze from multiple sources, including wearables, EHRs, and patient-reported outcomes. If data systems are not properly connected, researchers may be overwhelmed by the volume of data, leading to slower real-time analysis and loss of critical insights.
Regulatory agencies, including the FDA, support the adoption of DCTs but emphasize the importance of data security, interoperability, and a data management plan to maintain data integrity across multiple sources.
Using cloud-based solutions is the first step in ensuring data cohesion between systems. These systems integrate patient data from multiple sources in real time. Researchers can also incorporate a performance tracking system to quickly detect data gaps or inconsistencies, such as missing health data or incomplete patient surveys.
Unlike traditional clinical trials that operate from centralized sites, DCTs rely on home-based logistics, meaning equipment may be shipped directly to participants. Coordinating the timely delivery of study kits, wearables, and medication presents logistical challenges.
One study noted that some DCTs lasted longer than traditional trials simply due to the delay of drug shipments to patients’ homes. Combined with concerns like unreliable internet access, these delays can disrupt trial progression and real-time data monitoring.
To prevent these interruptions, researchers can partner with companies that specialize in DCT supply chains and reliable delivery of trial materials. Using wearables with built-in offline storage provides added security by ensuring continuous data collection even when internet access is unavailable. Plus, ensuring patients have access to technology tutorials, clear instructions, and live troubleshooting support will further set study coordinators up for success.
As DCTs become more common and increasingly utilized for their convenience and expanded reach, choosing reliable technology and strategies is more important than ever. Investing in patient-centered support, interoperable data systems, and efficient logistics planning ensures smoother trials with better outcomes. Looking to overcome DCT challenges and improve trial outcomes? Explore Vivalink's remote patient monitoring solutions today.