When UCB’s clinical research slammed into a brick wall as the pandemic hit, the midsized pharmaceutical company learned to trust the clinicians on the ground to protect their patients.
The Belgian company, which focuses on neurology and immunology, halted all studies in the face of uncertainty as the virus began to crop up in places beyond its origins in China.
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Research staff, such as Kim Doggett, head of site engagement, were tasked with slowly—and safely—getting everything back on track. The first step was setting up a COVID response team comprised of members across UCB’s organization—such as research, manufacturing, labs, commercial, all of it—to make decisions as a group.
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All new research was put on the back burner while Doggett and her team worked out how to continue to serve patients who were in the middle of research while maintaining the integrity of the studies themselves.
“We did not allow any new patients to start for safety reasons, because we were just not sure of the unknown,” Doggett said.
They listened to clinical researchers and site leads across the many countries where they had trials ongoing, quickly learning that much of the situation was outside their control as hospitals pivoted to confront COVID-19.
“We thought we were driving, so I will say that we were not driving at all,” Doggett said. “You were forced into a virtual world. And with that we just tried to make the best of it.”
Trust on the ground
Every country had different rules and situations to handle, so UCB had to lean on its partners in those regions to learn what was working and what wasn’t. There were differences among trials conducted in hospitals, private sites or clinics. UCB allowed people running the trials on the ground to dictate policy, rather than pushing their own ideas on each site.
“With every hospital, with every country, with every region within a country, they had set up their own contingency planning,” Doggett said.
UCB had to work around the changing responsibilities of their clinical staff, who were “doing double duty as front-line workers,” Doggett said.
“Some of them left their jobs in the clinic and doing clinical trials to go work in the hospital down the street to support any COVID response that was happening at a local level, so we had to keep that in mind,” she said.
Each trial had to grapple with new requirements for personal protective equipment, which of course was running scarce in the early days before manufacturing ramped up. Clinicians had to be tested for COVID-19 before entering trial sites and working with patients.
For trials that still required in-person visits, UCB had to work around clinicians’ schedules and social distancing requirements. They had to consider whether a patient would need to take a bus or whether they could drive to an appointment.
Zoom and FaceTime—or whatever digital tool was available at a given moment—were used to communicate with doctors. This ended up being a great way to connect to patients, too, according to the doctors, who found they could see more patients while never leaving their offices to dash between appointments.
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“We were doing anything and everything,” Doggett said, noting that she and her team were also navigating a new work-from-home situation on their end.
UCB delivered meds through the mail, which is something Doggett never thought the company would do.
“We typically never put our medication in the mail, but we worked very closely with all the regulators to make sure that we could do this,” Doggett said. “We kind of had to do whatever we had to do to make sure the patients were safe.”
Never again
UCB’s studies started back up around mid-May of 2020. Last year was a lot of work, but Doggett said UCB has learned one thing above all else: not to stop clinical research ever again.
“We will not stop trials, more than likely, in the future,” Doggett said.
“I can never say never,” she acknowledged, but seeing the medical community respond to protect patients from COVID gave her and UCB confidence that they can rely on those protocols in an emergency again. Even when travel was shut down, when the only personnel allowed in hospitals were essential workers, when patients had to be monitored remotely—the work got done through other means.
“We saw our healthcare workers really become the champions,” Doggett said. “We thought we were protecting our patients. They were protecting our patients—their patients, I should say.”
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Doggett said regulators such as the FDA were pushing for companies to bring the trial to the patient before COVID. UCB already had been focusing on decentralized trials and other virtual tools for clinical research, but the pandemic made it happen more quickly.
“This kind of forced us to really do it right,” she said.
UCB is now building contingency plans that can be used in another disruptive event, or even another wave of COVID. That means building on the idea of decentralized clinical trials to make studies more patient-centric and easing the burden on healthcare workers. These are all good developments that came out of an otherwise awful situation worldwide, Doggett said.
“I think it is the old normal, in that we're going to run trials and we want to create new medicines," she said. "The new normal is how we do it.”