Clinical trials drive medical innovation, but traditional models have barriers that prevent many from participating. Geographic restrictions, frequent site visits, and logistical challenges can make it difficult for patients to enroll and stay engaged.
These obstacles disproportionately impact rural communities, individuals with mobility issues, and underrepresented populations. As a result, research can lack diversity, which can limit how well study results apply to real-world patients.
The FDA has recognized these challenges and recently issued guidance supporting decentralized clinical trials (DCTs). Instead of requiring patients to visit a central research site for every check-in, DCTs bring the trial to them through telehealth, in-home assessments, and remote monitoring. By making participation easier and reaching underrepresented groups, these trials are making research more inclusive and reflective of real-world populations.
For decades, clinical trials required participants to travel to centralized research sites, sometimes across state lines, just to enroll and stay in a study. For patients in remote areas, those with limited mobility, or individuals balancing work and caregiving responsibilities, this was impractical.
Early concerns about patient safety and data accuracy made some researchers hesitant about DCTs, but advancements in wearable sensors and continuous monitoring have helped address these challenges. These technologies now collect real-time data wherever participants are, reducing the need for frequent site visits. With regulatory support and growing success, DCTs are breaking down longstanding barriers to participation.
Several trials have demonstrated that DCTs safely, accurately, and easily capture patient data. In a COPD trial, participants didn’t need to drive hours to a research site. Vivalink’s wearable ECG patch collected real-time data and transmitted it to the cloud, allowing researchers to monitor key health metrics remotely. Physicians tracked respiratory rate, heart rate variability, and activity levels without requiring frequent in-person visits, improving both data accuracy and patient convenience.
Historically, clinical trials have struggled with racial, ethnic, and gender diversity. Many studies fail to reflect real-world demographics, making it difficult to assess whether new treatments work equally well across different groups.
DCTs are helping to change that. A systematic review of decentralized methods found that 11 out of 13 studies reported better recruitment, while seven showed higher retention rates compared to traditional models. The review also identified a trend toward greater diversity in participants, particularly across race and geography.
By improving recruitment and retention, DCTs lead to stronger and more reliable study outcomes. When trials accurately reflect real-world populations, researchers can ensure that new treatments work for the patients who will ultimately use them.
Keeping participants engaged is a challenge in any clinical trial. For traditional trials, long site visits, rigid schedules, and wait times often lead to high dropout rates. Sponsors have tried to offset these burdens with transportation assistance or financial incentives, but these efforts haven’t led to sustained engagement.
DCTs remove key barriers by allowing patients to participate remotely. But flexibility alone doesn’t guarantee adherence. Some participants forget to use their devices. Others struggle with complicated technology or find the devices too disruptive. If the experience isn’t intuitive, participation can decline, along with data quality.
The right technology can prevent these challenges before they disrupt participation. In a hybrid trial, Vivalink’s wearable ECG and biometrics data platform improved adherence with a “wear-and-forget” experience. Instead of requiring manual input or constant adjustments, the devices automatically collected and transmitted data. Real-time monitoring and remote troubleshooting helped researchers catch and fix issues before they disrupted the study.
DCTs reduce reliance on self-reported symptoms and eliminate gaps between site visits. Wearable ECG monitors, continuous blood pressure trackers, and other remote monitoring tools provide real-time physiological data, allowing researchers to track changes as they happen rather than piecing together scattered data points.
This continuous data collection improves safety monitoring, speeds up treatment adjustments, and enhances trial efficiency. Researchers no longer have to wait weeks or months for follow-ups. They can detect safety concerns earlier and refine protocols in real time, reducing delays and improving study outcomes.
For many patients, home-based monitoring isn’t new. Individuals with hypertension, heart disease, or diabetes already track vitals remotely as part of routine care. DCTs build on these familiar habits, making trial participation feel like a natural extension of everyday health management.
Regulatory support, particularly from the FDA, has reinforced the credibility of DCTs and accelerated their adoption. The agency actively encourages the use of digital health technologies, including wearable sensors, mobile health apps, and remote patient monitoring tools, to improve trial accessibility and enhance data collection.
By shifting research away from rigid site-based models, DCTs allow participants to take part from home, local clinics, or wherever works best for them. As technology advances and regulations continue to evolve, DCTs will only become more efficient—accelerating drug development, enhancing study execution, and broadening patient access to treatments.
VivaLNK, Inc.
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Campbell, California 95008
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