Site Perspectives On Decentralized Clinical Trials

In the years before the global coronavirus pandemic took hold in 2020, clinical development strategies and trends were already shifting towards greater globalization, digitalization, and patient centricity. This shift, while slow, could be seen in multiple arenas: regulatory guidance advising on incorporating patient perspectives in trial endpoints such as the U.S. FDA’s 2021 draft guidance on the use of patient-reported outcome measures (PROMs) in oncology trials; sponsors’ initiatives on including more diverse patient populations; and rapid digitalization of business processes, enabling new approaches to trial conduct and patient engagement. The onset of the pandemic only accelerated the effects of these concurrent trends and factors, facilitated by technology.

Decentralized Clinical Trials (DCTs) saw a rapid uptick as patients were unable to travel to study sites due to travel restrictions and quarantines. This model of clinical trial design and conduct allows for certain activities (as specified in the clinical trial protocol) to take place away from traditional clinical research sites. It may come as a surprise to some that this model has existed for over twenty years, long before pandemic mitigation restrictions were put in place.

While DCT technologies have enabled patients and sites to participate in novel and innovative ways, there is a lack of qualitative and quantitative data on site perspectives on the use and implementation of these initiatives. To examine how this model has impacted site experiences, Medidata partnered with the Society for Clinical Research Sites (SCRS) to survey its members on a variety of DCT topics, including scope, perceived effectiveness, and enablement. Understanding clinical research sites’ experiences and perspectives on DCTs will help industry stakeholders – from sponsors and clinical research organizations (CROs) to regulatory agencies – refine trial design, operational procedures, and regulatory policy to better serve patients and sites while optimizing outcomes for the global health community.