Hybrid Clinical Trials: Merging Decentralized and Traditional Models

While remote trials have gained traction in recent years, not every study benefits from being fully virtual. Hybrid clinical trials blend traditional site visits with remote data collection to bring more flexibility to the research process.

Unlike fully decentralized trials, which rely on digital tools for nearly every step, hybrid trials allow sponsors to retain in-person touchpoints while reducing the need for frequent travel. This flexibility can improve recruitment, retention, and protocol adherence, especially for participants juggling work, caregiving, or chronic health conditions.

Tools like remote patient monitoring (RPM) and wearable sensors enable continuous data collection from home. With real-time visibility into patient status, research teams can monitor safety, adjust protocols when needed, and ease the burden on participants by limiting unnecessary site visits.

What Makes a Clinical Trial “Hybrid”?

With a hybrid trial model, some activities, like initial screenings or lab tests, still happen in person. But much of the day-to-day monitoring, such as tracking vital signs or symptoms, can take place remotely using connected devices. 

Wearable ECG patches, biosensors, and other digital tools are expanding the ability to collect high-quality data outside clinical settings. A centralized dashboard is necessary for aggregating and organizing incoming data in real time, giving research teams a continuous view of participant progress.

This infrastructure ensures that data collection continues even if patients miss a visit. At the same time, research teams gain access to more consistent data, which makes it easier to identify trends, flag concerns early, and keep trials on track.

Addressing the Challenge of Patient Adherence

Patient adherence has long been a challenge in clinical trials, and while hybrid and remote models aim to ease participation, they can introduce new barriers. When patients skip steps or stop using devices, gaps in data can affect protocol adherence and distort study outcomes. 

The reasons behind nonadherence vary. Some patients struggle with the technology itself. Older participants may have trouble pairing devices or remembering how to use them correctly. Others may find wearables intrusive or difficult to fit into daily life. And in many cases, motivation plays a role. If patients don’t see immediate benefits, they may lose interest.

The right tools can make a difference and should prioritize ease of use. Devices should arrive preconfigured to minimize setup. Real-time alerts should help study teams flag and address issues before they escalate. Educational materials, like videos or onboarding kits, can also give patients the confidence they need to stay engaged throughout the trial.

Vivalink’s Remote ECG in a Hybrid Trial 

In a recent hybrid clinical trial, a global CRO needed to monitor arrhythmias in hypertension patients while also tracking adherence and maintaining consistent data collection. To achieve this without relying on frequent site visits or home health support, the team partnered with Vivalink.

Patients used Vivalink’s wearable ECG patch during three separate 48-hour monitoring periods. Each device came preconfigured and ready to use, making it easy for patients to follow the study protocol at home. Real-time data monitoring gave study staff immediate visibility into patient activity and flagged issues such as missed sessions or improperly applied patches.

Vivalink also provided onboarding kits and training materials tailored to both patients and site staff. This reduced the learning curve and cut down on support requests.

The results:

• High patient adherence across all monitoring periods 
• Minimal disruption to trial operations 
• Reliable and real-time clinical data that helped keep the study on track 

Benefits of Hybrid Trials with RPM Solutions

With preconfigured devices and real-time monitoring, patients can participate in trials without major disruptions to their daily lives. That ease of use helps keep them engaged and following protocols over time.

When data is collected continuously and transmitted in real time, sites can spot problems early, whether it’s addressing a missed reading, resolving a device issue, or responding to a potential safety concern. That level of oversight is often harder to achieve in traditional trial models.

Hybrid trials also create opportunities for greater efficiency and cost savings. Sites spend less time coordinating in-person visits, and sponsors reduce spending on logistics, travel, and staffing. Reusable and rechargeable sensors add another layer of value, especially when used across multiple monitoring periods.

Continuous monitoring produces more consistent and high-quality data. Instead of relying on snapshots taken during site visits, sponsors get a more comprehensive picture of patient health over time, capturing trends, changes, and events that might otherwise go unnoticed.

Hybrid trials are reshaping how studies are designed and conducted. With the right remote monitoring tools, sponsors can improve data quality, enhance operations, and make participation easier for patients. Learn more about how Vivalink supports hybrid trial models.