Talk abounds of the “COVID catalyst” that forced clinical trial practitioners to quickly consider and often adapt new technologies and previously underutilized best practices to keep projects afloat at the height of the pandemic last year. Most experts agree that the deployment of decentralized clinical trials (DCTs) or hybrid variants is among the tactics that are here to stay. However, there’s wide-ranging debate on how the pace of DCT adoption is proceeding as COVID-19’s biggest threats to trial operations weaken.
“Unfortunately, I’d admit we’ve taken a step back” in terms of embracing DCTs and hybrid approaches, says JP Kappelle, vice president of strategy at 4G Clinical. While he’s a big fan and remains bullish on the overall trend, he’s observed in the past few months that many are “reverting” to defaulting to in-person trial operations rather than considering remote options. “We aren’t back to where we were before the pandemic, but we are seeing” a dip in the enthusiasm curve, he says.
The shift to DCTs and hybrid tactics has already had “a massive impact on the clinical trial ecosystem,” Kappelle says. They require very different types of business and operational acumen, technology, and workforce skill sets to thrive, he notes. “We’re in a transitional stage,” but DCTs and hybrid approaches are here to stay, he says.
Patients have gotten used to the conveniences of remote trials and won’t want to surrender them easily, Kappelle adds. “The voice of patients has become stronger as they understand [the availability] of remote options in trials,” he says. Older patients appear more eager to return to in-person services, when possible, he notes.
While the designers of today’s trials still tend to elevate remote options in their planning more than they might have before COVID-19, regulators, inadvertently or not, are not helping to usher in a golden age for DCTs and hybrids, Kappelle says. Acknowledging that DCTs are “adding a layer of new questions,” he says a lack of clear direction from global regulators is slowing adoption.
Kappelle believes service providers will continue to offer new solutions to better support remote clinical trial operations, though fundamental DCT and hybrid trial structures may not change too much in the coming years.
Author: Michael Causey