Decentralized clinical trials: Is this the next stop for clinical research?
There are several challenges researchers face when conducting clinical trials for rare diseases, including a small pool of potential participants and a limited number of dedicated treatment centers around the country that are often hard for participants to get to for frequent visits.
During a session at the 2021 SPLIT Annual Meeting, Evan D Muse, PhD, FACC, FAHA suggested that due to the pandemic, issues surrounding in-person visits has been thrust into the spotlight—not just for specialty care but for nearly the entire medical field—and has led to the need to reapproach many longstanding processes.
“One of the silver linings of the pandemic was our pivot to remote clinical trials,” he said. “We know that the only research that is going to get done now is stuff that we can do in a remote fashion. We can’t have our patients coming to clinic. We can’t be doing in-hospital research as avidly and with as much speed as we did prior to the pandemic.”
But we still need innovation and to drive new drug discovery, he said.
Dr Muse said there needs to be a “transition to a decentralized clinical trial and being able to harvest the power of individuals in their own space.”
With reliable mobile health technology more readily available, participants can provide continuous data as well as background analytics.
Moreover, Dr Muse said decentralized clinical trials have the potential to “provide us information about real-world outcomes not potentially limited to a clinical setting where things may not translate when we take it to a more pragmatic approach.”
This is already being done on a large scale, through the All of Us Research Program, run by the National Institutes of Health. The program aims to gather health data from 1 million volunteers to further the development of individualized care. In addition to accessing patients’ electronic health records, data can be collected from wearable devices.
Patients should be seen as partners in research, Dr Muse concluded.
Muse ED. New Approached to Mobile Health Technology. Presented at: 2021 SPLIT Annual Meeting.