Chances Are You're Already Doing Decentralized Clinical Trials

By Ben Baumann

If you're involved in the clinical research field, you've likely encountered the term “decentralized clinical trial” or DCT, which, at first glance, may not clearly convey its meaning. Traditionally, clinical trials are inherently decentralized, as they involve various distributed locations and sites. However, in recent years, “decentralization of clinical trials” has taken on a new connotation, referring to the increasing virtualization of clinical research. This transformation involves established virtual methods like electronic patient-reported outcomes (ePRO), electronic informed consent (eConsent), and eSource, along with more recent innovations such as digital health and direct integration with electronic health record (EHR) systems.

In practical terms, your study can be considered a DCT if you're engaged in activities such as electronically obtaining patient consent through smartphones or other devices, dispatching healthcare professionals to patients' homes for services like sample collection or treatment, interfacing with patients via televisits or video conferences, and equipping participants with connected devices to monitor their health digitally. DCTs are characterized by a shift away from the traditional clinical trial site's central role in favor of more direct participant interaction, often facilitated through a centralized virtual site. These advancements are made possible by web technology, clinical-grade sensory devices, and standardized data exchange protocols.

While this trial design can have many benefits, it also faces its fair share of challenges. Learn how to overcome these hurdles and make DCTs more effective and efficient by accessing the full article below.