Research News

Clinical research resumes ‘safely and carefully’

Doctor checking temperature on patient with face mask.

Now that clinical trials have reopened, some research that was handled remotely — or could not move forward at all — can now happen in person.


Published July 3, 2020

headshot of Sanjay Sethi.
“We have to think outside the box because of the pandemic. The traditional model has mostly been to bring the participant to the research site. We should be now figuring out how to take the research site to the participant. ”
Sanjay Sethi, Sanjay Sethi, professor of medicine and director
Clinical Research Office

Almost all UB research other than that focused on COVID-19 was paused on March 23. The move, a direct result of the growing pandemic, was made to reduce the risk of viral transmission.

As announced at the time by Venu Govindaraju, vice president for research and economic development, and Provost A. Scott Weber, it was a “difficult decision” made after a great deal of thought. “We understand these measures are not ideal,” they explained, “however, they are necessary at this time.”

Now, nearly four months later, a “research ramp-up” is underway. (Read more about UB’s plans to resume research activities.) This is especially true at UB’s Clinical and Translational Research Center (CTRC). While protocols inside and outside the building at 875 Ellicott St. have changed, researchers are ready to resume clinical research.

“We are fortunate that UB’s research support infrastructure has been 100% operational through the research pause and subsequent staged ramp-up,” says Govindaraju. “This enabled us to create and implement the Research Ramp-up Plan in collaboration with our campus partners.

“UB researchers have been very responsive to the phased ramp-up plan,” he continues, “and through a cooperative process with the academic units, every investigator who needs to conduct essential research and time-sensitive research has the ability to return to their research facilities. We encourage those who can function remotely to continue to do so. This limited return to facilities, combined with ongoing remote operations, allows us to resume time-sensitive research while focusing on the health and safety of our employees.”

“We’re very excited,” says Teresa Quattrin, senior associate dean for research integration in the Jacobs School of Medicine and Biomedical Sciences, and director of the Clinical and Translational Science Institute (CTSI) Special Populations core. She points specifically to clinical trials in diabetes and endocrinology “that are very cutting-edge. We want to give the opportunity [to participate] to our patients in Western New York and beyond.”

CTSI Director Timothy F. Murphy, SUNY Distinguished Professor and senior associate dean for clinical and translational research, has high praise for the researchers and staff members who have worked diligently to prepare for the return to clinical research.

“Our clinical researchers are anxious to get their studies restarted,” Murphy says. “Having said that, I am impressed with the careful and thoughtful planning that clinical research teams are doing to maximize the safety of participants and staff.”

Challenges of remote research — and in returning

Kimberly Brunton is co-associate director with Pamela Anderson of UB’s Clinical Research Office (CRO), which provides expertise and support to investigators conducting human subject research.

“We are anxious to get all of our research ramped up to full potential,” Brunton says, together with hospital affiliates and partners’ re-opening plans, since UB studies often involve use of these services and facilities.

For a clinical researcher like Quattrin, one element of the “return” means reopening clinical trials that were put on hold. In addition, some research that was handled remotely — or could not move forward at all — can now happen in person.

“It has been challenging,” she admits. “Some of the visits that were scheduled for patients who were already enrolled in clinical trials had to be conducted remotely, the best we could.”

The agenda also includes studies related to COVID-19, and its devastating effects in Western New York and beyond.

“As we ramp up clinical research studies that were paused, we will also continue to bring new clinical trials of drugs and vaccines related to COVID-19 to Buffalo,” Murphy says. “We are investigating approaches to conducting these studies safely, including remote sites for enrollment and follow-up.”

Ensuring safety for patients, staff and researchers

At the Clinical Research Center, an outpatient research clinic located in the CTRC, Brunton says all necessary precautions have taken place for the safety of the visiting participants, as well as the safety of staff.

“We have screening in place for anyone coming into the unit, and have established guidelines on PPE (personal protective equipment) use, disinfecting and social distancing that have been approved by the Office of the Vice President for Research and Economic Development,” she says. “We also provide pharmacy support for outpatient investigational drug dispensing. This will continue as other investigators come online and ramp up their studies.”

Ensuring safety is no simple task. That’s why, Quattrin explains, the university has established defined protocols for all researchers, staff and patients. “The biggest factor to consider first and utmost is the safety of everybody involved — not just the patients, but also personnel, and especially if the potential medicine may have an effect on an individual’s immune system,” she says.

Strict protocols are in place regarding who is interacting with the patient, Quattrin adds. Considerations include the path that the patient will travel to come to the center and identifying the most effective ways to limit contact between patient and staff.

“These are all steps that we’re putting in place in compliance with UB regulations and state regulations,” she says. “It’s essential to reopen, and to reopen safely and carefully, because this situation is here to stay. So, it would be a shame for people not to be able to take advantage of new potential advancements in a safe manner.”

Lessons for the future

Brunton notes that the experience “has been challenging, but it also has provided an opportunity to better work with our institutional partners in a more collaborative and productive manner.” This approach, she says, “has served the community well to date and will continue with the myriad of other studies we have planned and that are ongoing.”

Clinical Research Office Director Sanjay Sethi, professor and chief of pulmonary, critical care and sleep medicine in the Department of Medicine in the Jacobs School, says COVID-19 has caused a re-think in terms of how individuals can and will participate in research studies.

“We have to think outside the box because of the pandemic,” Sethi says. “The traditional model has mostly been to bring the participant to the research site. We should be now figuring out how to take the research site to the participant.”

Sethi believes recent adoption of new technologies to connect at-home individuals and health care professionals may have an impact on the future of clinical research.

The use of technology to conduct remote visits for clinical purposes could be adopted to conduct research visits,” he says. “There has been newfound flexibility because of the pandemic in many of the processes we had for establishing and conducting clinical research. It would be important to retain some of those enhancements and efficiencies once the dust settles down.”