Adjusting to the Virus Has Long-Term Advantages for Clinical Trials

The early days of the COVID-19 pandemic were an adjustment period for medical professionals across the board, but they brought up particular challenges for the Cancer Clinical Trial Office (CCTO) at the University of Colorado Cancer Center. A number of procedures that used to take place in person or in the office — collecting signatures from patients and doctors, delivering medications, submitting data to trial sponsors — suddenly had to be done in a whole new way.

CCTO staff sprang into action immediately, says Tiffany Colvin, director of clinical research operations for the CU Cancer Center, to look for solutions and work together for the sake of the patients.

“It took a shift and a higher level of collaboration, and people understanding, ‘This maybe isn’t in my scope, but we can do it, and get it done well,’ in order to fall within the regulations,” she says.

Accelerating electronic transformation

Colvin says the CCTO already was in the early stages of digitizing some processes when COVID-19 hit, but the pandemic made the switch to the electronic realm all the more imperative.

Tiffany Colvin

“We were thinking about how we could provide electronic consents, electronic documents, e-signatures — all of that was forthcoming,” she says. “What we didn’t expect was to be catapulted into that avenue and have to address it so quickly. It’s helped us advance to a place we knew at some point we were wanting to get to.”

Especially in the early days of the virus last spring, the CCTO dramatically reduced its footprint on campus due to state regulations on who could and couldn’t be in the office. “Technically we are not classified as essential personnel, yet we are,” Colvin says. “We provide so much of the care.”

Collaborating to benefit patients

In addition to accelerating the move to electronic procedures, including telehealth appointments, the CCTO expanded collaboration across the board. Those in the office stepped up to collect data for those who weren’t. The CCTO staff leaned more on doctors and nurses at UCHealth University of Colorado Hospital to collect vital signs, administer questionnaires, and deliver medicine. Staffers also had to pay attention to FDA guidance and to let institutional review boards know how trial operations were changing due to COVID. The number-one focus through it all, Colvin says, was taking care of CCTO patients.

“It was just constant change,” she says. “Constant adaptation in order to take care of the patient. Patients were either not going to come in — whether that was limitations on space or fear or any of those dynamics — or they were going to come in, so we needed to have the appropriate staff there to help provide what they needed.”

On a near-daily basis, Colvin was reacting to new guidelines or hospital rules, keeping staff informed, and figuring out in real time how best to keep operations moving.

“Our department is 140 people, and we have 10 disease sites,” she says. “I was part of early-morning or late-afternoon COVID calls to hear what the new changes were. Then it became about, ‘How do we get the providers what they need? How do we get the patients what they need? Who wants to take these additional tasks?”

Confronted by loss

Things were only complicated by the reality of having difficult conversations with — or even losing — patients during a time when person-to-person contact was limited, she says.

“Some of these coordinators have personal connections to patients they’ve known for months or years, and so navigating that — and sometimes not being able to have resolution around those who were passing during this time — was very difficult,” she says. “Loss is something we don’t have a course on. What we do have sometimes is that ability to have closure or say goodbye to someone, and that was very much removed during that time.”

Other difficulties arose around the companies sponsoring the clinical trials. The data sponsors were used to having direct access to was no longer available 24/7, and the CCTO data team had to work hard to get them the information they needed. A special OneDrive network helped, as did other software solutions the CU School of Medicine helped the CCTO put in place.

“The institution worked very hard during COVID, when budget cuts were everywhere and spending was really sheltered, to move e-regulations forward. That’s us not looking back, that’s moving forward,” Colvin says. “It could have taken a lot longer to get that off the ground, but the need was so crucial across our campus to be compliant in research that they kept moving it forward. We’re so grateful for that.”

Looking ahead

Like many other medical professionals, Colvin and the CCTO staff learned a number of lessons during COVID-19 that will serve them well going forward. One silver lining of the pandemic is that it accelerated so much change and forced researchers to take full advantage of technology.

“What we achieved in three months of my career — I still look back on that and think, ‘How in the heck did we do that?’” Colvin says. “Moving forward, we’re not going to go back and lose some of the advances we made, like electronic signatures or electronic routing of documents. We have to formally change those from a COVID memorandum to routine business guidance and standard operating procedures.”