If 2020 has been real-world evidence’s (RWE’s) audition, it appears to have won the part, according to a growing chorus of industry thought leaders, including ConcertAI CEO Jeff Elton.
As the COVID-19 pandemic began to cause in-progress clinical trials to stall or completely halt earlier this year, leveraging RWE emerged as a way to preserve some trials and avoid stoppages, Elton says. The slowing was “a super big problem” that was mitigated by use of the relevant retrospective data found in RWE, he notes, and harnessing RWE was part of a broader industry “pivot” to embrace new ways of conducting trials.
In addition to spurring the emergence of RWE in a more meaningful way, Elton says the pandemic ushered in a “new standard of care” that’s unlikely to go away once COVID-19 is just a bad memory. A more prominent role for RWE, increased use of telehealth, and other factors are “changing how decisions are being made” in clinical trial design and execution, he adds.
While most in the clinical trial industry appear to believe the way we’ve done things in the past has been forever altered by the pandemic, Elton adds another piece of potential evidence, citing the rush of emergency U.S. Food and Drug Administration (FDA) guidances issued earlier this year that were designed to speed trials and embrace technology, decentralization, and usage of RWE and real-world data and the like.
After the dust settles, “The FDA doesn’t usually remove those emergency guidances,” Elton says, meaning most of the changes implemented under some duress will remain in the future.
Use of RWE in 2020 has also “lowered the burden for patients and providers in running a study,” Elton says.
Elton also compares the rise of RWE with the rise of so-called decentralized trials. “Randomized clinical trials aren’t going away,” he says. Instead, expect to see blended models where RWE is used more than it had been in the past, just as trials are more likely to feature aspects of decentralization with traditional in-house and in-person patient contact remaining an integral part of the research routine.
Author: Michael Causey