Decentralized Clinical Trials: Meeting Patients Where They're At

While decentralized clinical trials (DCTs) have been a hot topic in the industry since they practically became a necessity during the COVID-19 pandemic, the trial design choice has been around for more than a decade. According to an article in Frontiers in Public Health, the earliest studies on the feasibility of “Internet trials” date back to 2003, and the first “Trial over the Internet” was patented in the U.S. in 2007. In 2011, it was reported that Pfizer completed its first decentralized clinical trial.

“The pandemic didn’t catalyze innovation. These tools existed,” says Craig Lipset, co-chair of the Decentralized Trials & Research Alliance (DTRA) and founder of Clinical Innovation Partners, a consulting agency that provides growth advisory services to organizations developing and implementing innovative approaches for clinical research and medicine development.

Since the widespread adoption of DCTs, the Food and Drug Administration (FDA) has defined them as trials that are “executed through telemedicine and mobile/local healthcare providers, using processes and technologies that differ from the traditional clinical trial model.” Therefore, DCTs shouldn’t be confused with virtual clinical trials, which were prompted by the pandemic and have no face-to-face interactions.

Learn more about the innovations DCTs provide for improved patient interactions and what’s on the horizon for these types of trials.