“It’s not reasonable, ethical, or fair to expect patients to go to a physical site when it’s not necessary” for the conduct of a clinical trial, says Harsha Rajasimha, founder and CEO of Jeeva Informatics Solutions.
Doing so puts an unfair burden on patients, caregivers, and even clinical trial practitioners, Rajasimha says. “If we are serious about patient centricity, it begins with giving patients choice in how trials are conducted and building that [input] into the protocol design at the earliest stages…not as an afterthought,” he notes.
Effective, patient-driven protocol design “minimizes the burden on patients to participate in a study,” Rajasimha says. “We’ve been expecting for far too long that patients will go to a brick-and-mortar clinic” for every clinical trial interaction, he adds.
He applauds what he calls a “paradigm shift” in acceptance and usage of elements of decentralized clinical trials (DCTs). “For 70 years we’ve been doing clinical trials in much the same way, but now we’re seeing a revolution in the form of patient centricity,” Rajasimha says. “DCTs are 100% here to stay.”
In fact, he expects their usage to increase in the coming years. “Early adopters” are driving usage now, and there’s been a “bell curve” of acceptance, just as is often witnessed in the evolution of any new technology, he notes.
On the other hand, Rajasimha agrees that DCTs are not designed to work in every situation. “Decentralization is not the goal, it is a means to an end” to give patients additional options, he says. “In some cases, [DCTs] aren’t an option. Some people also just like in-person visits even” when they aren’t strictly necessary, he adds. “We’re not replacing all trials with remote visits.”
However, “when there’s an opportunity to leverage remote options to help patients, we should examine it closely,” Rajasimha says.
Author: Michael Causey