Revised Clinical Trial Rules During COVID-19 Pandemic May Benefit Patients

David Gerber, MD, Associate Director, Clinical Research, Harold C. Simmons Comprehensive Cancer Center

The COVID-19 pandemic has led to new rules and expectations for clinical trials. Following guidance from federal agencies, institutions such as UT Southwestern (UTSW) adjusted clinical trial operations. To protect patient safety, changes such as utilizing remote consents, conducting telehealth study visits, and shipping oral study treatment to patients’ homes have streamlined the clinical trial participation process.

A survey of UTSW clinical research professionals found that most clinical trial coordinators, managers, and nurses report positive experiences with these COVID-related adjustments. In fact, a majority are in favor of keeping the new protocols even after the pandemic ends.

“With COVID-19, we’ve seen more changes to clinical trial practices than at any other time in my career,” says David Gerber, MD, a professor of internal medicine at UTSW, associate director of clinical research in the Harold C. Simmons Comprehensive Cancer Center, and first author of an article on the survey results published online in the Journal of the National Comprehensive Cancer Network. “My hope is that this whole ordeal leads to long-term simplification of the clinical research process.”

On March 16, UTSW announced restrictions on clinical trials in response to COVID-19, halting new enrollments and cutting back on in-person, nonessential research visits for ongoing trials. Two days later, the U.S. Food and Drug Administration issued its own guidance, allowing clinical researchers to make temporary changes to trial conduct, including implementing telehealth appointments and allowing electronic signatures. This guidance remains in effect until the official COVID-19 national emergency is ended by the federal government. The National Institutes of Health also issued revised trial guidance.

“Shutting everything down for new enrollment was a hard decision for us, but ultimately we had to consider what was best for patients,” says Erin Williams, associate director of clinical research operations at the Simmons Cancer Center. “Our goal was to get everything reactivated as quickly as possible, but we needed time to figure out how to make clinical trials work in the wake of COVID-19.”

Before ramping clinical trials back up, Williams’ team had to cross many technical barriers. Those included putting systems into place for researchers and patients to remotely access documents and information, as well as new ways for researchers to communicate virtually with patients.

From April 27 to June 1, the Simmons Cancer Center gradually resumed clinical trial enrollments, but with new measures in place. For instance, patients no longer had to visit in person to consent to participate in a trial, with that process being shifted to video calls and electronic signatures. Moreover, some patients who previously had to visit the Simmons Cancer Center to receive drugs could now have them shipped to their homes, and some visits to check on patients’ progress or symptoms were converted to telehealth calls.

Gerber, Williams, and their colleagues saw the changes as an opportunity for research. Roughly a month after the new procedures were launched, they invited 108 UTSW clinical research professionals to participate in a webinar and respond to an e-mailed survey about the changes. Ninety-four responded to the survey, including administrative professionals who coordinate trial logistics and finances, research nurses, research managers and coordinators, and data specialists.

Overall, survey respondents said that the changes had a positive impact on patient safety, treatment efficacy, patient and staff experience, and communication with patients, investigators, and sponsors. More than 90% thought that it was pretty important, important, or very important to continue any positive COVID-19-related clinical research adjustments after the pandemic ends.

Edited by Gary Cramer