Why Cellular Connectivity is Critical for Decentralized Clinical Trials

In the last decade, the clinical research and telehealth landscape have undergone a shift. Traditional trials, once tied to brick-and-mortar sites, are evolving into more flexible, patient-oriented models. However, decentralized clinical trials (DCTs) are not a new concept completely. The first (fully) decentralized clinical trial was conducted by Pfizer in 2011, but hybrid models had laid their foundation in the early 2000s.

These two models are what the name suggests – full DCTs are 100 percent remote with no provider to patient interaction, while hybrid models include elements of in-person and remote visits. The two alike utilize mobile health technologies and connected medical devices but go a step further by incorporating tools for recruitment, retention, and virtual visits.

The Rise of DCTs in Recent Years

Decentralized clinical trials gained even more traction during the COVID-19 pandemic when remote monitoring became a necessity rather than a convenience. These trials shift data collection and patient interactions away from research sites to patients’ homes, which are supported by telemedicine, mobile apps, and wearable health devices. Benefits of DCTs include:

• Enhanced Patient Engagement & Experience – In traditional healthcare settings, patients are required to visit doctors to receive care. DCTs help remove these barriers by making healthcare more accessible and convenient for a wider population. The online format offers limited exposure with one another, reducing the risk of viral transmission.
• Increased Patient Recruitment & Retention – DCTs offer broader reach and accessibility for providers to their patients. Traditional clinical trials are often limited by geography. By leveraging digital tools, DCTs can remove many of these logistical barriers. This opens participation to a more diverse population, including rural and underserved communities and individuals with mobility challenges. This convenience is then typically translated into higher retention rates.
• Accurate Data Collection & Monitoring – Technology can help improve the reliability of patient data collected by healthcare providers and is the foundation of any successful clinical trial. In traditional trials, data is typically captured during site visits, providing only snapshots of the patient’s condition. In fully DCTs, connected devices continuously collect real-time data, such as heart rate and glucose levels.

Why Cellular Connectivity is Ideal for DCTs

As decentralized clinical trials become more widespread, cellular connectivity plays a critical role in enabling seamless communication and reliable data transmissions. Cellular networks offer distinct advantages over broadband for decentralized trials: ubiquity, reliability, and scalability:

• Reaches much farther than broadband, especially in rural areas; therefore, encouraging patient engagement and retention.
• In environments where Wi-Fi is unstable or unavailable, cellular serves as a reliable primary connection or failover option. This is critical for uninterrupted data transmission to ensure patient safety and data integrity.
• For those with limited technology skills, it ensures that the device is always connected without relying on the patient to connect the device to a home Wi-Fi network.
• And lastly, cellular-enabled devices can be pre-configured and shipped directly to clinical trial patients. It’s ready to go out of the box (a service Kajeet specializes in).

Kajeet eliminates these barriers with fully managed, white-glove logistics services:

• Devices arrive pre-configured with activated SIMS, ready to transmit data out of the box
• Staging, kitting, labeling, and provisioning are all handled by our warehouse team
• All device activity can be monitored and controlled through our Sentinel platform

Check it out: Tulane University has recently enrolled their first round of patients in the HEARTBEAT study. This decentralized clinical trial uses cellular-connected smartwatches and AI to monitor participants. The trial aims to improve early detection and prevention of cardiovascular diseases through decentralized, real-time data collection and analysis. Learn more here.

How We Can Help with Decentralized Clinical Trials

Kajeet’s connectivity solutions for clinical trials are specifically designed to meet the needs of life science and medical device innovation. We go beyond offering data plans, providing a comprehensive, end-to-end solution that supports every stage of your trial. Want to learn more about how our multi-carrier LTE & 5G access can ensure coverage almost anywhere in the US while also making it easy to manage connected devices using our Sentinel platform? Learn more on our IoT Solutions for Clinical Trials page or reach out to one of our IoT experts!