Clinical Research Resumption Underway at Jacobs School

Published July 28, 2020

Jacobs School of Medicine and Biomedical Sciences faculty members are encouraged by the phased-in return of clinical research.

“We have to think outside the box because of the pandemic. ”
Professor of medicine and chief of the Division of Pulmonary, Critical Care and Sleep Medicine
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Almost all research at UB other than what was focused on COVID-19 was paused March 23 to reduce the risk of transmission of the novel coronavirus.

‘Excited’ for Return of ‘Cutting-Edge’ Trials

Teresa Quattrin, MD

“We’re very excited,” says Teresa Quattrin, MD, UB Distinguished Professor of pediatrics and senior associate dean for research integration.

She pointed, for example, 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.”

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,” says Quattrin, director of the Clinical and Translational Science Institute’s (CTSI) Recruitment and Special Populations Core. “Some of the visits that were scheduled for patients who were already enrolled in clinical trials had to be conducted remotely as best we could.”

High Level of Preparedness

Timothy F. Murphy, MD

Timothy F. Murphy, MD, SUNY Distinguished Professor of medicine 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,” says Murphy, director of the Clinical and Translational Science Institute. “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.”

“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.”

Officials Forced to ‘Think Outside the Box’

Sanjay Sethi, MD

Sanjay Sethi, MD, professor of medicine and chief of the Division of Pulmonary, Critical Care and Sleep Medicine, says that COVID-19 has caused officials to rethink how individuals can and will participate in research studies.

“We have to think outside the box because of the pandemic,” says Sethi, assistant vice president of health sciences and medical director of UB’s Clinical Research Office (CRO). “The traditional model has mostly been to bring the participant to the research site. We should now be figuring out how to take the research site to the participant.”

Sethi believes the 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.”

Safety of Researchers, Staff, Patients Essential

“We are anxious to get all of our research ramped up to full potential,” says Kimberly Brunton, co-associate director (with Pamela Anderson) of the CRO, which provides expertise and support to investigators conducting human subject research.

At the Clinical Research Center, an outpatient research clinic located in UB’s Clinical and Translational Research Center, Brunton says that all necessary precautions have taken place for the safety of the visiting participants as well as the safety of staff. To ensure health and safety, UB has established defined protocols for all researchers, staff and patients.

In addition, strict protocols are in place regarding who is interacting with the patient. 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 and state regulations,” Quattrin says. “It’s essential to reopen, and to reopen safely and carefully, because this situation is here to stay, at least for a period of time. So, it would be a shame for people not to be able to take advantage of new potential advancements in a safe manner.”