In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in April, Dr. Emily O’Brien and Dr. Adrian Hernandez discussed challenges for pragmatic trials during the COVID-19 pandemic and lessons for the future of the healthcare system.

“We certainly did see some degree of disruption, but I was impressed by the flexibility in the ability to adapt that all of our NIH Collaboratory Trial teams showed,” said O’Brien. “Some of them mentioned the support of having the Cores and consultations with experts in real time to be able to make adjustments,” she said.

O’Brien is a an associate professor in population health sciences at Duke University and a cochair of the NIH Collaboratory’s Patient-Centered Outcomes Core. Hernandez, the executive director of the Duke Clinical Research Institute, is a co–principal investigator of the program’s Coordinating Center. View the full interview.

O’Brien and her colleagues at the NIH Collaboratory Coordinating Center conducted a brief survey about the impacts of the pandemic on the NIH Collaboratory Trials, such as challenges they encountered, solutions they implemented, and any new measures the study teams started using.

“The impacts on the NIH Collaboratory Trials [included] research staff being redeployed to COVID-19 studies or clinician-scientists moving into predominantly clinical care roles as opposed to research roles,” O’Brien explained. “The most obvious impact of those changes was delays across projects. It took longer to get things done, to enroll patients. That was felt pretty universally by our projects, although there were several projects that were further along, had enrollment mechanisms that were in place and already up and running that were less impacted by those delays,” she said.

Some study teams also reported a renewed commitment from their partnering healthcare systems to work together as they encountered challenges in trial implementation.

Hernandez added, “For many studies, we thought they would actually stop. And for traditional trials, that’s what happened. But for [the NIH Collaboratory Trials], since they’re closer, more embedded within healthcare systems, part of the delivery process, they were able to flex because by nature they have to for any environment that changes.”

When asked what the COVID-19 pandemic has taught about what is needed for the future, Hernandez said, “It’s not too different than, say, what we have with the Defense Production Act…. What we need is essentially the equivalent of that, a ‘Pandemic Response Production Act,’ so that healthcare systems can be organized, coordinated to generate evidence around what’s needed for the response.”