UTSW & the Move to Patient-Centricity-based Clinical Trials in the Age of COVID-19

UTSW & the Move to Patient-Centricity-based Clinical Trials in the Age of COVID-19

COVID-19 has led to a wave of new rules and a new set of expectations involving clinical trials as research centers such as UT Southwestern modified their clinical trials operations.  With patient safety always front and center, the process had to be streamlined to deal with a new reality of constraint—for example, patients couldn’t travel so research needed to go virtual. This means that centers such as UT Southwestern had to utilize remote consents, telehealth and move generally from a site-intensive to patient-centric experience. UTSW recently completed a survey of clinical research professionals about all of these changes. The overwhelming response has been positive: clinical trial coordinators, managers and nurses like the changes and a majority don’t want to go back to the past but stay with the future.

Wisdom from Harold C. Simmons Comprehensive Cancer Center

The events of the last several months represent unprecedented change reported David Gerber, MD, professor of internal medicine at UTSW and first author of an article reporting on the survey results. This paper was published in the Journal of the National Comprehensive  Cancer Network. Dr. Gerber, also an associate director of clinical research recently shared “With COVID-19, we’ve seen more changes to clinical trial practices than at any other time in my career.”  He continued “My hope is that this whole ordeal leads to long-term simplification of the clinical research process.”  

COVID-19 & The Onset of a New Reality

On March 16, UT Southwestern 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 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.”

Ramping Up in a COVID World: Patient-Centricity

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 – a lengthy process that involves learning about the risks and benefits of participation. That process was 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.

“Things behind the scenes changed, too,” says Williams. “Our workflow and that of any sponsoring pharmaceutical company are very different now.”

Responses to Changes

Gerber, Williams, and their colleagues saw the changes as an opportunity for research. On May 22 – 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 emailed 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. Of those, 58 percent had more than five years of professional experience with clinical research and 56 percent had personal experience with a COVID-19-related change.

A Positive Impact

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 percent thought that it was pretty important, important, or very important to continue any positive COVID-19-related clinical research adjustments after the pandemic ends.

Recommended Changes 

For some specific changes, those who had firsthand experience with the new protocols were more likely to recommend continuation. For instance, 61 percent of respondents who had used telehealth were in favor of keeping it going, compared with 36 percent of those who had not used this technology. Similarly, 63 percent of those who had been involved in shipping therapies were in favor of the practice continuing, while only 29 percent of those without experience shipping therapies suggested the practice continue.

“It goes to show that things that might look or sound complicated from the outside are actually less scary when you’re the one who gets it worked out and does it,” Williams says.

Research professionals with more than five years of experience in the field also were more open to keeping the changes in place. “I think the longer someone works in clinical research, the more they tend to question the status quo,” Gerber says.

Funding for Study

This research was supported in part by a National Cancer Institute Midcareer Investigator Award in Patient-Oriented Research (K24CA201543-01), the Biostatistics Shared Resource of the Harold C. Simmons Comprehensive Cancer Center (5P30 CA142543), and UT Southwestern Academic Information Systems (CTSA NIH grant UL1TR001105).

About UT Southwestern Medical Center

UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes, and includes 23 members of the National Academy of Sciences, 16 members of the National Academy of Medicine, and 13 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,500 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT? Southwestern physicians provide care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases, and oversee approximately 3 million outpatient visits a year.