Decentralized Trials: The Reality Behind the Buzzword

By Blake Adams, Florence Healthcare

The concept of decentralized clinical trials is not new, but in response to COVID disruptions, research operations leaders were forced in 2020 to accelerate their plans for remote and virtual trials. 

In response, decentralized clinical trials have become a primary innovation in the clinical operations ecosystem. But the meaning of the term “decentralized clinical trials” is not universally understood.  

What are Decentralized Clinical Trials? 

Decentralized clinical trials are clinical trials that use technology and processes that differ from traditional methods to enable the localization of clinical trial operations through medical professionals or direct-to-patient capabilities. 

In 2019, Scott Gottlieb, M.D. and Commissioner of the FDA, states, “Second, we also see great potential in using digital technologies to bring clinical trials to the patient, rather than always requiring the patient to travel to the investigator. This is an FDA priority,” and continues in saying, “This approach, called decentralized clinical trials, can help move prospective collection of data from the real-world — including randomization — outside of the brick and mortar boundaries of traditional clinical research facilities, tapping into not only EHRs but additional digital health tools like wearable devices.” (1)

Here are five things you need to know about decentralized clinical trials: