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Revised clinical trial rules during COVID-19 pandemic may benefit patients, survey shows

Feedback from UTSW clinical cancer research professionals indicates positive impact of adjustments on patient and staff experience

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David Gerber, M.D., conducts a telehealth visit with a cancer patient. Adjusted protocols for cancer clinical trial participation such as increased use of telemedicine have been largely viewed as positive by UTSW research professionals surveyed.

DALLAS – Oct. 13, 2020 – The COVID-19 pandemic has led to new rules and expectations for cancer clinical trials. Following guidance from federal agencies, institutions such as UT Southwestern’s Harold C. Simmons Comprehensive Cancer Center led efforts to adapt 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 cancer clinical trial participation process.

A survey of UTSW clinical cancer 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, M.D., a professor of internal medicine at UTSW, associate director of clinical research in the Simmons Cancer Center, and first author of an article on the survey results that were published online this month 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.”

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“I think the longer someone works in clinical research, the more they tend to question the status quo,” says Gerber, associate director of clinical research for the Harold C. Simmons Comprehensive Cancer Center.

In March 2020, the Food and Drug Administration issued guidance on the conduct of clinical trials during the COVID-19 pandemic. The National Institutes of Health also released suggested guidelines. Implementing these recommendations required major changes to operations, including establishing systems for researchers and patients to remotely access documents and information as well as new ways for researchers to communicate virtually with patients.

“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,” says Erin Williams, MBA, administrative director of Clinical Research Operations at the Simmons Cancer Center.

As a result of these measures, 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 study medications could now have them shipped to their homes. And some visits to check on patients’ progress or symptoms were converted to telehealth calls.

“Many of these COVID-19-related changes address long-standing concerns about cancer clinical trials,” Gerber says. “For years, there have been calls to simplify trial protocols and procedures, which have become highly complex and burdensome on patients and their families. Without such reform, trials will be accessible and relevant to a shrinking minority of patients.” 

Gerber, Williams, and their colleagues saw the changes as an opportunity for research. On May 22 – roughly a month after the new clinical research procedures were launched – they invited 108 UTSW clinical cancer 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.

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 cancer research adjustments after the pandemic ends.

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.

Cancer 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.

Other UTSW researchers who contributed to this study were Thomas Sheffield, M. Shaalan Beg, Valerie Clark, Yang Xie, Blair Holbein, Celette Sugg Skinner, and Simon Craddock Lee.

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

Beg is a Dedman Family Scholar in Clinical Care; Xie holds the Raymond D. and Patsy R. Nasher Distinguished Chair in Cancer Research, in Honor of Eugene P. Frenkel, M.D.; and Skinner holds the Parkland Community Medicine Professorship.

The Simmons Cancer Center is the NCI-designated cancer center for UT Southwestern and affiliates. It is one of the premier centers in the country for transdisciplinary cancer research and discovery, clinical trials, exceptional cancer care and impactful community engagement. The only NCI-designated cancer center in North Texas, the Simmons Cancer Center supports 13 multidisciplinary teams of clinicians and researchers woven together to bring broad expertise to bear on the scientific and clinical challenges unique to different cancers. These experts provide access to compassionate, high-quality multidisciplinary patient care including clinical trials. The Simmons Cancer Center is also member of the National Comprehensive Cancer Network.

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.