Fully Remote, Hybrid, Or Flexible Hybrid Decentralized Trials?

The COVID-19 pandemic has had a profound and lasting impact on how businesses function, evident in the widespread adoption of remote work. While certain aspects of business undeniably thrive through in-person interactions, remote work offers numerous advantages over traditional operations in various domains. One such domain has notably benefited from the pandemic-driven shift towards remote practices in clinical trials within the life sciences.

Known as decentralized clinical trials (DCTs), these remote clinical trials emerged in contrast to traditional clinical trials conducted exclusively at a single research site. With the advent of the pandemic and the subsequent need for remote medical care, these trials started taking place and later took on the term "decentralized." While DCTs adhere to the same fundamental principles as other remote endeavors, leveraging technology to reduce in-person interactions, participants are no longer required to travel to research sites, as technology facilitates the capture and reporting of trial data to researchers.

To ensure that the new style of clinical studies and digital tools met regulations, the Federal Drug Administration (FDA) requires technology utilization for remote communication with study participants and data collection. Several commonly employed technologies in DCTs include eConsent, telemedicine, online participant portals, centralized data collection applications, and mobile devices.

This ebook explores the benefits of DCTs compared to traditional trials, presents relevant examples, and offers guidance on selecting the most suitable type of remote trial for a specific study.