What's Missing From Decentralized Trials? The Human Element

By Michele Richardson and Jasmine Stacey, Medical Research Network

DCTs offer many advantages over traditional, fully site-based trial designs, including increasing enrollment opportunities for rare diseases, serious illnesses, and underrepresented patient populations. When sites need help enrolling patients, sponsors increasingly turn to DCTs to fill the gaps. But despite their popularity, many PIs are wary of DCTs, assuming that remote patients won’t receive the same high standard of care at home as they do at a site. However, the most effective DCTs provide in-person care at the patient’s home or community. The difference between these DCTs and traditional trials is merely location, not quality of care.

Running a clinical research site can be overwhelming, as study coordinators and PIs juggle sponsors and solution providers while performing patient care. Sites are at the heart of the trial, and their workloads are high. Managing patient care and data-heavy administrative duties can leave sites with little time or energy to work with DCT providers. Solution providers respond more effectively to their needs when they develop direct relationships with sites. Maintaining these relationships means more than simply responding to emails — checking in regularly with sites, having one-on-one conversations about their enrollment and support needs, and advocating for them. A dedicated site management team can build and maintain the relationships necessary to maximize DCTs’ value and create flexible, patient-centric clinical trials.