The Centricity Of Decentricity: Breaking Down The Basics Of Decentralized Clinical Trials

Over the past year, the Clinical Trials Enterprise (CTE) made tremendous progress digitizing and decentralizing various elements of the participant and site experience. As COVID continued to spread, sponsors rapidly digitized a number of key trial elements, replacing paper forms and physical visits with electronic consents (eConsent), electronic Clinical Outcome Assessments (eCOA’s), and remote visits (TeleVisits).

This shift not only kept trials running during the pandemic, but also presented participants with more choice about how they engage in studies. In fact, for perhaps the first time, the CTE presented participants with consumer-style engagements that offered convenience (any time, anywhere), reduced burden (removing transportation and paper burden and facilitating realtime data availability), and mirrored the lifestyle technologies they were already accustomed to using in their daily lives through smartphones and other technologies.

As the industry rushed to respond to the pandemic’s demands, many study teams acquired individual point solutions to address a specific need in a study, such as an eConsent solution or ePRO offering. For those who are unfamiliar with the term, point solutions may be loosely defined as individual electronic systems that take the place of manual clinical trial processes.

Thus, many sponsors ended up with one system for electronic consents, another for ePRO’s, and often another for TeleMedicine. While these e-solutions were instrumental in keeping trials afloat, they often combined in inefficient ways. For instance, when point solutions do not share common interfaces, devices, and underlying data structures, they create underlying data issues as a result of “siloization”, while offering disparate and suboptimal trial experiences for patients, sites, or study teams.